Vital Sync remote monitoring may not receive bedside monitor alarms
Covidien is recalling the HealthCast Vital Sync Remote Patient Monitoring System after complaints that alarms from the primary patient bedside monitor were not transmitted to or received by the remote system.
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: Rubric level 3 covers risk-of-harm products where injury has not yet been reported: alarms may not reach the remote monitoring system, and no injuries are stated in the source.
Plain-English summary
Covidien LLC is recalling the HealthCast "Vital Sync" Remote Patient Monitoring System, product numbers VSLBASE03P / VITALSYNCSW03 and VSLBASE04P / VITALSYNCSW04, covering Vital Sync versions 3.3.1, 3.4.0, 3.4.1, 3.4.2, 4.0.0 and 4.0.2. The Vital Sync Informatics Manager routes and stores medical device data and diagnostic information from supported devices to the Virtual Patient Monitoring Platform, third-party annunciation systems, electronic medical records and clinical information systems. About 78 systems were distributed across 22 US states and to Spain. The FDA has classified this recall as Class II.
The recall follows complaints and investigations stating that alarms from the primary patient bedside monitor were not alarming or being transmitted and received on the remote patient monitoring system.
Each version carries its own UDI-DI, listed in the FDA enforcement record.
Facilities can identify affected systems by the product number and version above, and may contact Covidien LLC for further information.
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
- Affected units
- 78
Distribution
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