FDA recall, , Moderate risk
HealthCast "Vital Sync" Remote Patient Monitoring System
Alarms from the primary patient bedside monitor may not be transmitted or received on the remote system.
Summary by Recall Canary from the FDA notice
What happened
Covidien LLC, based in Boulder, Colorado, is recalling its HealthCast "Vital Sync" Remote Patient Monitoring System because alarms from the primary patient bedside monitor may not be transmitted or received on the remote system, according to the FDA. The recall involves 78 systems and began on January 30, 2026, with the FDA adding it to its Enforcement Report on March 11, 2026.
The product is software used with the Vital Sync Informatics Manager. The recall was initiated due to complaints and investigations about the alarm issue. The systems were distributed nationwide in the United States, including states such as Alaska, California, Florida, New York, and Texas, as well as in Spain.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Match the list below, then check the codes the FDA notice also names.
A UDI-DI is the device identifier printed with the barcode on the device label.
HealthCast "Vital Sync" Remote Patient Monitoring System
- UDI-DI
- 10884521844933
- 10884521844940
- 10884521847569
- 10884521856127
- 10884521849358
- 10884521856134
- Model number
- Vital Sync 3.3.1Vital Sync 3.4.0Vital Sync 3.4.1Vital Sync 3.4.2
From the FDA notice
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).
Recall details
- Company began the recall
- Sold in
Worldwide - U.S. Nationwide distribution in the states of Alaska, Alabama, Arizona, California, Florida, Georgia, Illinois, Indiana, Kentucky, Louisiana, Michigan, Minnesota, Mississippi, North Carolina, New York, Ohio, Oklahoma, Oregon, South Carolina, Tennessee, Texas, and Virginia. The country of Spain.
- Company
- Covidien LLCBoulder, Colorado
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98407
- Recall number
- Z-1557-2026
- Quantity recalled
- 78 systems
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
Summary updated
