Reported Mar 18, 2026 · Ongoing
HealthCast "Vital Sync" Remote Patient Monitoring System which consists of: Product Number: VSLBASE03P / VITALSYNCSW03…
Covidien LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Covidien LLC · 6135 Gunbarrel Ave · Boulder, CO · 80301-3214
Is this the product you have?
- HealthCast "Vital Sync" Remote Patient
- Monitoring System which consists ofProduct
- NumberVSLBASE03P /
- VITALSYNCSW03 Model / UDI-DI codesVital 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 NumberVSLBASE04P /
- VITALSYNCSW04 Model / UDI-DI codesVital 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)
- Lot codes and dates
- HealthCast "Vital Sync" Remote Patient
- Monitoring System which consists ofCFN: VSLBASE03P / VITALSYNCSW03 UDI-DI (GTIN); 10884521844933
- Serial NumberVital Sync 3.3.1
- CFNVSLBASE03P /
- VITALSYNCSW03 UDI-DI (GTIN)10884521844940
- Serial NumberVital Sync 3.4.0
- CFNVSLBASE03P /
- VITALSYNCSW03 (OUS only) UDI-DI (GTIN)10884521847569
- Serial NumberVital Sync 3.4.1
- CFNVSLBASE03P /
- VITALSYNCSW03 UDI-DI (GTIN)10884521856127
- Serial NumberVital Sync 3.4.2
- CFNVSLBASE04P /
- VITALSYNCSW04 UDI-DI (GTIN)10884521849358
- Serial NumberVital Sync 4.0.1
- CFNVSLBASE04P /
- VITALSYNCSW04 UDI-DI (GTIN)10884521856134
- Serial NumberVital Sync 4.0.2
- Amount recalled
- 78 systems
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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