February 5, 2025 – Philips has issued an urgent medical device correction impacting its MCT or Event Diagnostic Service utilizing the Philips MCT during the period of July 2022-July 2024.
Authors
Molly Sachdev, MD; Amit J. Shanker, MD; Lisa Miller, MS; Anne Marie Smith, MBA; Kenneth A. Ellenbogen, MD; Christopher F. Liu, MD
Correspondence
[email protected]
Recall Issue Summary
During the period between July 2022 and July 2024, Philips has recognized that a small percentage of ECG events received into their Monitoring Service Application (MSA) were not properly routed, and thus, not reviewed by a technician for potential inclusion on reports. This issue was due to a software configuration issue related to the MSA, which was subsequently corrected.
No devices are being removed from the market, and additional monitoring and control protocols have been implemented. However, some End of Service reports from this time period may have incomplete information, i.e., some clinically relevant arrhythmias may not have been included. Furthermore, some of these arrhythmias may have met criteria for practitioner notification. Philips has identified these events to include algorithm-identified episodes of atrial fibrillation, pause, supraventricular tachycardia, ventricular tachycardia, and 2nd or 3rd degree AV block.
At present, Philips has voluntarily reported 109 cases of device malfunctions and 2 adverse events reported as death to the FDA. The role of the system, if any, with regards to the deaths is unknown – causation due to arrhythmia has not been established.
Manufacturer Recommendations
Philips is offering the opportunity to have the individual Prescriptions reprocessed to include ECG events not initially routed to a technician. A dedicated Prescriber Response Site has been created where details of the impacted patients can be viewed, and from which providers will be able to identify which patients’ data should be reprocessed.
Subsequently, a Delta Summary Report demonstrating the differences between the original and reprocessed findings will be forwarded to the provider. In addition, Philips recognizes that for high volume providers/institutions with large numbers of impacted patients, reprocessing is burdensome, and they are working on remedies to lighten the impact.
HRS Recommendations
HRS strongly encourages its members worldwide to read the Philips provider notification correspondence and review their list of impacted patients. The decision to reprocess should be individualized, based on provider clinical judgement. Possible considerations include length of time since monitor was placed, monitoring indications, patient characteristics and subsequent clinical evaluations performed.
Reporting Contact
Adverse reactions or quality problems experienced in the United States should be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Should you have any questions about this notice, contact Abbott Technical Services at 1-800-722-3774 (U.S.) or +4684744147 (Europe).
Topic
- Regulatory
- Regulatory Agencies
- U.S. Food and Drug Administration (FDA)
Resource Type
- Safety Alerts
Manufacturer
- Philips
Device Type
- Other
FDA Class
- Class I
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