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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Monitoring Devices

HealthCast Vital Sync Remote Patient Monitoring System Recalled for Alarm Failure

Agency Publication Date: March 11, 2026
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Summary

Covidien LLC has recalled 78 HealthCast Vital Sync Remote Patient Monitoring Systems because alarms from primary patient bedside monitors may fail to transmit to the remote monitoring system. This software-based defect means that critical patient alerts might not be received by healthcare staff. The recall affects several versions of the Vital Sync software, including versions 3.3.1 through 4.0.2.

Risk

If a bedside monitor detects a life-threatening change in a patient's condition but fails to transmit that alarm to the remote monitoring station, medical staff may not be alerted to provide urgent care. This could lead to serious injury or death due to delayed medical intervention.

What You Should Do

  1. Identify if your facility is using the HealthCast Vital Sync Remote Patient Monitoring System software versions 3.3.1, 3.4.0, 3.4.1, 3.4.2, 4.0.0, 4.0.1, or 4.0.2.
  2. Check the model and software version numbers on your system configuration. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled product. Contact the manufacturer or your distributor to arrange return, replacement, or correction.
  4. Call the FDA: 1-888-463-6332 (1-888-INFO-FDA) for additional questions regarding this medical device recall.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: HealthCast "Vital Sync" Remote Patient Monitoring System
Variants: Vital Sync 3.3.1, Vital Sync 3.4.0, Vital Sync 3.4.1, Vital Sync 3.4.2, Vital Sync 4.0.0, Vital Sync 4.0.1, Vital Sync 4.0.2
Model / REF:
VSLBASE03P
VITALSYNCSW03
VSLBASE04P
VITALSYNCSW04
Serial Numbers:
Vital Sync 3.3.1
Vital Sync 3.4.0
Vital Sync 3.4.1
Vital Sync 3.4.2
Vital Sync 4.0.1
Vital Sync 4.0.2
UDI:
10884521844933
10884521844940
10884521847569
10884521856127
10884521849358
10884521856134
GTIN:
10884521844933
10884521844940
10884521847569
10884521856127
10884521849358
10884521856134

The Vital Sync Informatics Manager is software intended to route and store medical device data.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 98407
Status: Active
Manufacturer: Covidien LLC
Sold By: direct-to-hospital sales; medical equipment distributors
Manufactured In: United States
Units Affected: 78 systems
Distributed To: Alaska, Alabama, Arizona, California, Florida, Georgia, Illinois, Indiana, Kentucky, Louisiana, Michigan, Minnesota, Mississippi, North Carolina, New York, Ohio, Oklahoma, Oregon, South Carolina, Tennessee, Texas, Virginia

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.