[pending] HealthCast "Vital Sync" Remote Patient Monitoring System which consists of: Product Number: VSLBAS
Pending LLM rewrite. Source: FDA_DEVICE Z-1557-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
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.
The recalled product
- Product
- 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 /
- Manufacturer
- Covidien LLC
- Category
- Medical Device — Devices
Distribution
Distributed nationwide across the United States.
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