U.S. flag An official website of the United States government

On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

U.S. Food and Drug Administration
  1. Home
  2. Medical Devices
  3. Medical Device Safety
  4. Medical Device Recalls
  5. Outpatient Telemetry Correction: Philips Issues Correction for Monitoring Service Application used with Mobile Cardiac Outpatient Telemetry Due to Potential for Missed Information or Notifications That May Impact Patient Care Impact
  1. Medical Device Recalls

Outpatient Telemetry Correction: Philips Issues Correction for Monitoring Service Application used with Mobile Cardiac Outpatient Telemetry Due to Potential for Missed Information or Notifications That May Impact Patient Care Impact

This recall involves correcting certain devices, and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it without correction.  

Affected Product

  • Product Names: Monitoring Service Application for Mobile Cardiac Outpatient Telemetry MCOT (BTPS-1000)

What to Do  

  • Check the Philips Prescriber Response Site at https://prs.gobio.com to review which patients who had outpatient electrocardiogram (ECG) monitoring may need to have data reprocessed (data collected from July 2022 to July 2024). 

On December 18, 2024, Philips sent all affected customers an Urgent Medical Device Correction recommending the following actions: 

  • Review Philips’s Frequently Asked Questions for this issue (see below). 
  • Log into the Prescriber Response Site at https://prs.gobio.com with the Location Code provided in the letter header. 
  • Read and acknowledge receipt of the Urgent Medical Device Correction letter on the website.
  • Review your patient list and choose patients for reprocessing. 
    • Options include reprocessing All, None, or Selected patients.

Philips will not communicate with patients directly about this issue. If patients have been impacted as part of this issue, health care providers have the responsibility to inform patients and/or update a patient’s care pathway.

The firm also provided a list of Frequently Asked Questions for this issue, including: 
 

  • How can I identify my impacted patients?
    • A list of your patients who have been impacted is included for review in the Prescriber Response Site.
  • What is the Prescriber Response Site?
    • A secure site (https://prs.gobio.com) containing your impacted patient list.  
    • This is also the site where Philips will post reprocessed ECGs, resulting in either a Delta Summary Report or a notification that no changes occurred to the reporting.
  • What actions are required of my clinical practice?
    • Log on to the Prescriber Response Site with the provided Location Code and your NPI.  
    • Read and acknowledge the receipt of this Urgent Medical Device Correction Letter.
    • Review list of patients and select whether you wish reprocessing to be performed on all or none of your patients; you will also be able to select individual specific patients on the site.
  • What actions are planned by Philips if I choose to have the Delta Summary Report generated?
    • Philips will generate a Delta Summary Report for the selected patients and send them via the Prescriber Response Site for review.  
    • You will be notified via the email provided during the acknowledgement process when your reports are ready for review.
  • How will newly identified Urgent and Emergent events be handled?
    • Newly identified events will be included in the summary report.
    • Events newly identified as Urgent or Emergent will not be notified to practices via routine communication channels.
  • Whom do I contact if I become aware of an adverse reaction or quality problem experienced because of this software configuration issue?
    • If you need any further information or support concerning this issue, please contact our Prescriber Response Line at 888-521-1684.

Reason for Correction

Philips and their subsidiary Braemar Manufacturing are correcting the Monitoring Service Application, a service related to Mobile Cardiac Telemetry Monitoring (BTPS-1000)
after identifying that some ECG events received into the Monitoring Service Application from July 2022 to July 2024 were not properly routed. As a result, these events were not reviewed by a cardiology technician for potential reporting to the ordering clinician. This may have led to missing information in reports or missed notifications, both of which could have impacted a health care provider’s clinical decision making.

Some of the ECG events received into the application during this time period met criteria to be escalated back to ordering practitioners, but were not escalated to them. These events include algorithm-identified episodes of atrial fibrillation or pause, supraventricular tachycardia, ventricular tachycardia, and second or third degree AV block.

The use of affected product may cause serious adverse health consequences, including longer periods of undetected or untreated irregular heartbeats (arrhythmias) and death.  

The FDA is aware of 109 reported injuries and 2 reports of death related to this issue.

Device Use

The Philips (Braemer) Monitoring Service Application software is intended to process, analyze, display, and report symptomatic and asymptomatic cardiac events in ECG data received from compatible devices. The data is then reviewed by qualified health care professionals. It is not intended for use on patients with potentially life-threatening arrhythmias who require inpatient monitoring.

Contact Information  

Customers in the U.S. with questions about this recall should contact Philips’ Prescriber Response Line at 888-521-1684. 

Additional FDA Resources

Additional Company Resources

Unique Device Identifier (UDI)

The unique device identifier (UDI) helps identify individual medical devices sold in the United States from manufacturing through distribution to patient use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified, and problems potentially corrected more quickly. 

How do I report a problem?

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program. 

Subscribe to Medical Device Safety and Recalls

Sign up to receive email updates on medical device recalls, safety communications, and other safety information.

Back to Top