FDA Recall Notices

Reason for Recall

The 866173 lntelliVue G7m Anesthesia Gas Modules could have a component issue that may trigger an interruption of the gas measurement. This issue concerns the G7m's sample gas pump which could stop working, producing a technical, INOP (inoperable) alarm. The pump may fail prematurely when there is friction caused by an abrasion. This recall is for an IMPORTANT PRODUCT NOTICE dated 1/18/23.

Corrective Action

An IMPORTANT PRODUCT NOTICE dated 1/18/23 was sent to customers. The actions planned by Philips to correct the problem A Philips representative will reach out to you to arrange a replacement of the sample gas pump. Affected products and how to identify them Affected product is the 866173 lntelliVue G7m Anesthesia Gas Module. Both the product number and the serial number on the G7m product is contained on the back of the product, preceded by "REF" and "SN", respectively. If you need any further information or support concerning this issue, please contact your local Philips representative.

Reason for Recall

Devices with Option CP2 and initially programmed to software version P.01.01 were configured incorrectly at the factory. Therefore, Enhanced ECG Capabilities provided by Option CP2 were not enabled in these devices. Without Option C01 Full Arrhythmia, the device will not provide the yellow alarms for enhanced arrhythmia detection. This is a retrospectively reported recall from 6/14/23.

Corrective Action

PHILIPS issued Urgent Field Safety Notice (2023-CC-HPM-019) on 6/14/23. Letter states reason for recall, health risk and action to take: " Please be aware that without Option C01 (Full Arrhythmia) the device will not provide the yellow alarms for enhanced arrhythmia detection. " Review the contents of this letter with your staff. " Pass this notice to all those who need to be aware within your organization or to any organization where the affected devices might have been transferred. 5. Actions taken by Philips to correct the problem Philips Representative will contact you to arrange reload of current device's software to enable missing software options (C0l, C13, C51, C54). If you need any further information, please contact your local Philips representative

Reason for Recall

Potential for Internal Sound Amplifier to malfunction which could delay treatment.

Corrective Action

On 11/20/08, Philips began sending the URGENT-Medical Device Correction letter to their consignees via e-mails. On 11/21/08, the firm sent out the recall letter via United State Postal Service. The letter states the affected device as Philips IntelliVue Information Centers, running on the HP rp5700 PC platform equipped with an active speaker solutions using a DB-15 to 3.5 mm cable set. The consignees are advised to ensure that the audible alarm system is clear, free of noise and distortion and adjustable to different sound levels which is explained in p. 5-47 "Adjusting Alarm Tone Volume" of IntelliVue of the Instruction for Use, Release K Manual, supplied with the hardware, Philips Part Number 453564062301. Consignees can call Philips Healthcare Customer Care Service Center at 1-800-722-9377, #3, #1 and reference FCO 99862012.

Reason for Recall

Philips Intellivue and Avalon Fetal Monitors in time-synchronized automatic/sequence mode, the NBP automatic measurement series is stopped

Corrective Action

Philips Healthcare issued on 10/3/14 the Urgent Medical Device Correction notification/Field Safety Notice. The letter informs customers of the issue, identifies details of the units affected, gives instructions on actions to be taken by the customer and identifies what action Philips plans to take to remedy the issue. The correction will consist of a software upgrade free of charge. A Philips Healthcare representative will contact customers with affected devices to arrange for service. Philips is asking customers to follow the Action to be Taken by Customer/User section of the Urgent Medical Device Correction notification/Field Safety Notice: During the interim period until the SW is upgraded please make sure, if the NBP repetition interval needs to be increased (e.g. from 5 to 15 minutes), to restart the automatic NBP measurement. Please review this information with all members of your staff who need to be aware of the contents of this communication. It is important to understand the implications of this communication.

Reason for Recall

Unexpected pulse oximetry (Sp02) readings (100%) over time when sensor is not attached to patient. In addition, with a sensor attached to a patient, an incorrect high Sp02 may be displayed when a pulse rate is in a range of 185BPM

Corrective Action

Philips issued a Customer Letter and Urgent Device Correction letter to consignees on 09/21/06. Users were notified of the problem and provided with Instructions to Mitigate Risk. A software upgrade to: version D.00.61 and Sp02 FW A.01.46 is mandatory.

Reason for Recall

Philips IntelliVue MX40 Patient Wearable Monitor Configuration Setting Disables Generation and Delivery of ECG Alarms to PIIC iX

Corrective Action

The firm, Philips Healthcare, sent a "Field Safety Notice (FSN)" dated 9/14/2016 to its customers. The notice described the product, problem and actions to be taken. The customers were instructed to make sure that the MX40 Patient Wearable Monitor local configuration setting 'Alarms On' is configured to its factory default until your software is upgraded; and follow the instructions listed in the letter. A Philips Healthcare representative will contact customers with affected devices to arrange for the installation of the software upgrade. If you need any further information or support concerning this issue, please contact Philips Customer Support at 1-800-722-9377.

Reason for Recall

Distorted ST-Segment when using 12-Lead ECG Monitoring with Philips IntelliVue Patient Monitors

Corrective Action

Philips sent an Urgent Medical Device Correction letter to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were informed that Philips will provide software update and is provding interim instructions for the operator. For questions contact your local Philips representative.

Reason for Recall

Sp02 and/or Non Invasive Blood Pressure (NBP) alarms may become disabled without visual notification

Corrective Action

The firm, Philips Healthcare, issued a "URGENT-Field Safety Notice" on 12/19/14 to inform customers of the issue, identify details of the units affected, instructs on actions to be taken by the customer and identify what action Philips plans to take to remedy the issue. Philips will provide a software correction free of charge. Philips is asking customers to follow the Action to be Taken by Customer/User section of the Field Safety Notice-To prevent this issue from occurring, customers/users should: 1) Disable the Change Bed Label field in Patient Management. This is accomplished by changing the feature from Optional to Hidden 2) All patient transfers must be performed using the Transfer key in the Manage Patient application. Remember that the most reliable method of patient monitoring combines close personal surveillance with correct operation of monitoring equipment. If you need any further information or support concerning this issue, please contact your local Philips Healthcare Customer Service representative or the Customer Care Solutions Center at (800) 722-9377 with questions or concerns about this Device Correction.

Reason for Recall

Software: Scheduling function of the Philips Intellivue Clinical Information Portfolio Releases D.00 through D.03. Edits to a scheduled even frequency order may result in pending interventions not being generated after the first 24 hours.

Corrective Action

Philips Healthcare issued an Urgent Medical Device Correction letter dated October 15, 2010 to customers. Customers are asked to follow the guidelines in the "Action to be taken by Customer/User" section of the Urgent Medical Device Correction Notice until they receive their software correction. The correction will be in the form of a software upgrade and will be performed by Philips service personnel. Contact Philips Customer Care Center with questions or concerns about this correction at 1-800-722-9377

Reason for Recall

A software defect exists in the ICIP Release 0.02 scheduling function for order management such that if a user edits either the Schedule Time or the Stop Time for an existing order, the corresponding intervention(s) for the order may not be created.

Corrective Action

Philips Medical Systems notified accounts by letter on October 21, 2009, of the release ICIP version D.03, which contains a software correction . A Philips representative will schedule the implementation of this upgrade. Please contact the Philips Customer Care Center with questions or concerns about this correction at 1-800-722-9377.

Reason for Recall

Alarm failure : If changes are made to the Caregroup Editor configuration, Care Group alarm status, including alarm text and prompt tones, may fail to be displayed or annunciated at bedside monitors within the Care Group

Corrective Action

Philips Medical notified customers by letter dated November 2007 titled : Urgent Medical Device Correction Notice. Customers will be instructed to follow the Procedure to Mitigate Risk section * of the notice while they await the correction of their devices with a mandatory software upgrade to be performed by service representatives. * (no changes are to be made to the Caregroup Editor configuration on any system. If changes have already been made to the configuration prior to receipt of this notification, turn each bedside monitor "off " and then "on" in order to reset the system-Customer Care Contact telephone 1-800-722-9377)

Reason for Recall

Internal audio cable may have diminished retention force due to damaged contacts, which could lead to intermittent or loss of audible alarms.

Corrective Action

Philips sent an URGENT - Medical Device Correction letter dated November 9, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Philips is conducting a voluntary correction to replace the audio cable on affected devices. Customer were instructed to follow the "Action to be taken by CustomerUser" section of the instructions. Customers with wquestions were instructed to contact their Phililps representataive or contact the Customer Care Solutions Center at (800) 722-9377. For questions regarding this recall call 978-687-1501.

Reason for Recall

Speakers on IntelliVue X2 and IntelliVue MP2 may fail, identified by the display of a Speaker Malfunct. INOP or by the absence of audible sound, may result in delayed treatment of the patient.

Corrective Action

Philips North America issued Customer notifications on 11/18/2020 to US customers, via priority mail. Philips Market Organizations are responsible for distributing the letters outside of the U.S. Letter states reason for recall, health risk and action to take: Philips is asking users to follow the Action to be Taken by Customer/User section of the FSN: Affected products may continue to be used while awaiting replacement of the speaker, provided that the user routinely checks for the display of the Speaker Malfunct. INOP at power-up. If you experience this INOP or there is no sound from your X2 / MP2 speaker while it is not connected to another audible alarm annunciation system, remove the device from use and contact your local Philips service representative Philips representative or Philips Customer Support at 1-800-722-9377 Please complete the attached Reply Card and return it to Philips as soon as possible. Philips will replace affected speaker assemblies free of charge. A Philips Healthcare representative will contact you to arrange for the replacement of the speaker assembly in the listed affected devices.

Reason for Recall

A problem has been detected in the Philips IntelliVue MX4O that, if it were to occur, could affect the performance of the equipment. The volume of the MX4O speaker in these devices may be diminished or not audible above 4,500 feet when operating in Monitor Mode. These devices may intermittently exhibit Speaker Malfunct INOP messages after the Power On Self-Test. The issue is only apparent when the device is being used in Monitor Mode at an altitude of greater than 4,500 feet.

Corrective Action

On November 9, 2018, the firm notified customers of the issue via Customer Information Letters. The letter discussed the product problem. Customers are asked to confirm speaker behavior. It is recommended that the clinical user reboot the MX40 prior to entering Monitoring Mode to confirm proper operation of the speaker. Customers are also asked to complete the attached Reply Card and return to Philips as soon as possible. The firm will replace affected devices used at above 4,500 feet (1,372 meters). If you need any further information or support concerning this issue, please contact Philips Customer Support at 1-800-722-9377.

Reason for Recall

Central Station Monitoring Information Centers may experience sreeen freeze, i.e. loss of display, keyboard or mouse lock up

Corrective Action

Philips Medical Systems notified users by Certified Mail on/about 2/19/03 that the firm was initiating a device field correction (recall) to conduct an upgrade to units witha HP VL400 or VL420 computer which is cconfigured for dual display by replacing the video and network communication card. Previous to this notification, Philips sent letters on 1/2/03 addressed to Biomedical Engineering Manager to advise users to reboot the system in the event of a system freeze.

Reason for Recall

Once a surveillance station is restarted on January 1, 2018 or later, the station will be unable to perform patient discharge and transfer operations. Any subsequent attempt to perform these operations will cause the station to restart, resulting in a short period of loss of monitoring at the Surveillance station during such restart. Until this issue can be corrected, users should avoid intentionally restarting their Surveillance stations in 2018.

Corrective Action

To avoid this issue, do not intentionally restart any surveillance stations that have been running normally since the new year. You may use the workflows described in attachment Alternative Workflows for PIIC iX to avoid operations that may cause the surveillance station to restart. When a patient is discharged, confirm that the patient is discharged. Philips has initiated a correction to address this issue and will provide this software update to customers with affected devices at no charge. Software updates for PIIC iX A.0x and B.0x are expected to be available by January 8th. A Philips Healthcare representative will contact customers with affected devices to arrange for correction of the issue. Contact your local Philips representative if you have a question about any device affected by this issue.

Reason for Recall

Table Mounts assembled with incorrect length hardware may fall

Corrective Action

Philips issued an "Urgent Medical Device Correction" notification to all potentially affected customers on 10/22/08 via UPS for the US customers. The letter mailed to customers outside the US by Philips' regulatory contacts in each country via a tracked method. The letter informs customers of the problem and gives instructions on how to identify affected table mounts. Field Service Engineers will be dispatched to each customer site to inspect each Table Mount. If customers detect any sign of a loose connection between the monitor and the mounting plate while they are awaiting the Field Service Engineer, they are instructed to make sure that the monitor is not in a position to fall. They are asked to disconnect the monitor from the table mount. For additional information, contact Philips Medical Systems at 1-978-687-1501.

Reason for Recall

Potential issue where the IntelliVue monitors did not alarm.

Corrective Action

An URGENT Medical Device Correction notice, dated 10/31/25, was mailed to customers and distributors. Distributors were notified of this correction and instructed to forward the provided recall notification to all consignees. Additionally, distributors are asked to include their contact information for consignees in the provided response form and perform a good faith effort for each customer to obtain a completed response form. Consignees are instructed to notify all users of this recall notification and forward the notice to all who need to be aware within their organization or where affected devices were potentially transferred. Consignees are to re-evaluate and reconfigure device configuration per the provided instructions. Once recall actions have been completed, consignees are to complete the provided response form either via QR code, by email to [email protected], or by fax to 877-499-7223. Philips is planning to develop a software update which will enforce the additional confirmation step when the user enables infinite Alarms Off for IntelliVue MP5 models only. Consignees with any questions can contact Philips at 800-722-9377.

Reason for Recall

The ST elevation alarm on the Patient Monitor or standalone X2 Measurement Module will not sound when indicated for all chest leads derived using Hexad 12-Lead ECG Monitoring in the Host Monitor

Corrective Action

Philips Healthcare issued the Field Safety Notice on January 4, 2016, and informed customers of the issue, identifies details of the units affected, gives instructions on actions to be taken by the customer and identifies what action Philips plans to take to remedy the issue. Philips is asking customers to follow the Action to be Taken by Customer/User section of the Field Safety Notice: Until your software is upgraded, please make sure that the ST Analysis is switched ON when using STE measurement in the Hexad 12-lead ECG Monitoring. This can be done by entering the ST Analysis Menu and select ST Analysis to On. For more detailed information, please refer to the Instructions for Use (IFU) of your host monitor or to the X2 Measurement Module IFU. Philips will provide a software correction free of charge. For further questions please call (978) 659-3000.

Reason for Recall

Reconstructed ECG leads viewed or printed at the Information Center iX may misrepresent the ECG waveform in specific leads.

Corrective Action

Philips Healthcare issued a Field Safety Notice on 11/25/15 to inform customers of the issue, identifies details of the units affected, gives instructions on actions to be taken by the customer and identifies what action Philips plans to take to remedy the issue.Philips will provide a software correction free of charge. On 1/28/16 the Philips issued an updated letter to users.Philips has initiated a correction to address this issue. A software correction will be provided to customers with impacted devices at no charge. Philips is asking customers to follow the Action to be Taken by Customer/User section of the Field Safety Notice: Arrhythmia alarms are not affected. ST alarms, ST values and measurements are also not affected and could be used to assist with the decision to obtain a diagnostic ECG. The ECG waves at the bedside are not affected. Printing ECG waves from the bedside is an alternative to printing from the PIIC iX. If you need any further information or support concerning this issue, contact your local Philips Healthcare Customer Service representative or the Customer Care Solutions Center at (800) 722-9377 with questions or concerns about this Device Correction.

Reason for Recall

Some PAS-201 active speaker assemblies in use with the Philips IntelliVue Information Center (PIIC) have experienced intermittent audio or loss of audio. Speaker failures may delay recognition of an alarm condition, if operators do not recognize that there is no alarm sound from the monitor and the monitor is not connected to another audible alarm annunciation system.

Corrective Action

Philips notified all affected customers with an Urgent Medical Device Correction notification letter dated December 17, 2010. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to observe their system for any of the described symptoms. If they experience intermittent audio or there is no sound from their PAS-210 speaker while it is not connected to another audible alarm annunciation system, customers were instructed to remove the speaker from use and contact their local Philips service representative. Customers were advised not to rely exclusively on the audible alarm system for patient monitoring, the most reliable method of patient monitoring combines close personal surveillance with correct operation of monitoring equipment. ACTIONS PLANNED BY PHILIPS Philips will replace affected speaker assemblies free of charge. A Philips Healthcare representative would contact the customer when the replacement was available. Field Service Engineers will remove and replace defective speakers to correct the problem. The defective speakers will be returned to vendor (Beach Wire) to be discarded. This correction will be done free of charge for customers.

Reason for Recall

Philips has discovered that the Instructions for Use (IFU) for the IntelliVue TcG10 Transcutaneous Gas Measurement Module is missing the contraindication that the device is not to be used on patients under gas anesthesia.

Corrective Action

Customers were notified of the recall by letter sent via UPS on November 19, 2014. The Field Safety Notice informs customers of the issue, identifies details of the units affected, gives instructions on actions to be taken by the customer and identifies what action Philips plans to take to remedy the issue. Philips asked customers to do the following: Upon receipt of this notification, ensure that the IntelliVue TcG10 addendum to the Instructions for Use is being reviewed and implemented by all members of your staff who operate the device. Review this information with all staff members who are involved in the operation of the IntelliVue TcG10 modules and need to be aware of the contents of this communication. The addendum should be stored with the IntelliVue TcG10 Instructions for Use. If you need any further information or support concerning this issue, please contact your local Philips representative or call us at 1-800-722-9377.

Reason for Recall

Lithium-ion Rechargeable Batteries for the Philips MX4O Wearable Monitor may have a manufacturing defect that may affect the operation of the monitor

Corrective Action

Philips issued an email on January 25, 2019 informing customers the batteries on hold had been inadvertently shipped. Philips is asking customers to follow the Action to be Taken by Customer/User should check all MX40s that may contain an affected battery, immediately remove any affected batteries found and replace them with unaffected batteries. The batteries should be returned with the RMA number and return label provided by Philips following any special requirements for shipping lithium-ion batteries specified by the carrier they select

Reason for Recall

May experience a loss of centralized monitoring.

Corrective Action

Philips sent an Field Safety Notice on December 27, 2016, to customers via certified mail. The notice explains the issue and informs the customers that no actions are required. The product may be used until the replacement cable is made available. If you need any further information or support concerning this issue, please call your local Philips Representative at (800) 722-9377.

Reason for Recall

Potential failure to alarm for "No Device Data" INOP. The device to alarm after a Hamilton ventilator is disconnected from the EC10 Module or IntelliBridge I/O board.

Corrective Action

Philips began notifying consignees on about 01/15/2025 via certified letters titled URGENT Field Safety Notice and URGENT Medical Device Correction letters. Consignees were instructed to ensure that there is no interruption of the cable connection between the Hamilton ventilator and the EC10 Module or IntelliBridge I/O board before use, provide the notification to all affected personnel and customers if the devices have been further distributed, and to complete and return the response form provided. A Philips representative will contact you to schedule a visit from a Philips Field Service Engineer who will upgrade your ED245 Driver from revision A.0 to revision A.1. Distributors were instructed to return the Response Form attached your contact information, send the attached URGENT Field Safety Notice to each customer to whom you have distributed any affected device as soon as possible and no later than 5 days, together with the Reply Card, perform a good faith effort to get the Response Form by following up with the customer with a minimum of three attempts, and if possible, using multiple contact methods, inform Philips about the responses received, and implement the Technical solution established by Philips as soon as available within the timeframe communicated by Philips and confirm to Philips the implementation in all affected products. In case a product is not corrected, inform Philips on the reason why the technical solution cannot be implemented.