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FDA-Device2026-03-18Class IIPROCESSING DEFECT

Covidien Vital Sync remote patient monitoring system recalled for alarm transmission failure

Covidien LLC
OTHERNationwide distribution

Check your Vital Sync monitoring system for alarm issues

The Covidien HealthCast Vital Sync remote patient monitoring system has a defect that can prevent critical patient alarms from being transmitted from bedside monitors to remote monitoring stations. This means clinicians may not receive timely alerts about patient condition changes. The FDA has identified 78 affected systems.

  • Contact your facility's biomedical or IT department if your site uses Vital Sync versions 3.3.1, 3.4.0, 3.4.1, 3.4.2, 4.0.0, or 4.0.2
  • Do not rely solely on remote monitoring until you confirm your system is not affected or has been updated
  • Follow your facility's interim monitoring protocols for all patients
  • Check for any firmware or software updates from Covidien
Hazard

Due to complaints and investigations stating that alarms from the primary patient bedside monitor was not alarming/being transmitted and received on the remote patient monitoring system.

Sold states
Worldwide - U.S. Nationwide distribution in the states of AK, AL, AZ, CA, FL, GA, IL, IN, KY, LA, MI, MN, MS, NC, NY, OH, OK, OR, SC, TN, TX, and VA. The country of Spain.
Affected count
78 systems
Manufactured in
6135 Gunbarrel Ave, N/A, Boulder, CO, United States
Products
HealthCast "Vital Sync" Remote Patient Monitoring System which consists of: Product Number: VSLBASE03P / VITALSYNCSW03 Model / UDI-DI codes: Vital Sync 3.3.1 / 10884521844933 Vital Sync 3.4.0 / 10884521844940 Vital Sync 3.4.1 / 10884521847569 (OUS Only) Vital Sync 3.4.2 / 10884521856127 Product Number: VSLBASE04P / VITALSYNCSW04 Model / UDI-DI codes: Vital Sync 4.0.0 / 10884521849358 Vital Sync 4.0.2 / 10884521856134 The Vital Sync" Informatics Manager is software that is intended to route and store medical device data and device diagnostic information from supported devices to the Virtual Patient Monitoring Platform, 3rd Party Annunciation Systems, Electronic Medical Record (EMR) and Clinical Information System (CIS).

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1557-2026

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