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MEDICAL DEVICE RECALLMODERATE

HealthCast Vital Sync Remote Patient Monitoring System

HealthCast is recalling Vital Sync software due to a failure to transmit or receive critical patient bedside monitor alarms.

What to do

Contact your clinical engineering or IT department to verify if your facility is using an affected software version and follow the manufacturer's instructions for system updates or mitigation.

Posted
Updated
Recall No.
Z-1557-2026
Agency
Firm
Covidien LLC
Recall ID
98407
Status
ONGOING

Why it was recalled

The Vital Sync Informatics Manager software is being recalled because alarms from primary bedside monitors may fail to transmit or be received by the remote patient monitoring system. This issue affects specific software versions and UDI-DI codes used for routing and storing medical device data.

Is mine affected?

Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.

ProductUPCRecall #
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 intend10884521844933, 10884521844940, 10884521847569, 10884521856127, 10884521849358, 10884521856134Z-1557-2026
HealthCast "Vital Sync" Remote Patient Monitoring System which consists of

Where it was sold

Distributed nationwide.

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Editorial summary by Recall Canary · last updated 2026-06-11 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification