Covidien Vital Sync remote patient monitoring system recalled for alarm transmission failure
The Covidien HealthCast Vital Sync remote patient monitoring system has a defect that can prevent critical patient alarms from being transmitted from bedside monitors to remote monitoring stations. This means clinicians may not receive timely alerts about patient condition changes. The FDA has identified 78 affected systems.
From the FDA notice · Read the official notice ↗ · All Covidien LLC recalls
What to do
- Contact your facility's biomedical or IT department if your site uses Vital Sync versions 3.3.1, 3.4.0, 3.4.1, 3.4.2, 4.0.0, or 4.0.2
- Do not rely solely on remote monitoring until you confirm your system is not affected or has been updated
- Follow your facility's interim monitoring protocols for all patients
- Check for any firmware or software updates from Covidien
Is yours affected?
Compare your label or packaging with 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 / 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).
- Sold in
- Nationwide
- Made for
- All ages (0 months and older)
Details
- Units affected
- 78 systems
- Illnesses reported
- None reported
- Manufactured in
- 6135 Gunbarrel Ave, N/A, Boulder, CO, United States
- Classification
- Class II
- Recall number
- Z-1557-2026
In the FDA's words
- Description
- 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). 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. HealthCast "Vital Sync" Remote Patient Monitoring System which consists of: CFN: VSLBASE03P / VITALSYNCSW03 UDI-DI (GTIN); 10884521844933 Serial Number: Vital Sync 3.3.1 CFN: VSLBASE03P / VITALSYNCSW03 UDI-DI (GTIN): 10884521844940 Serial Number: Vital Sync 3.4.0 CFN: VSLBASE03P / VITALSYNCSW03 (OUS only) UDI-DI (GTIN): 10884521847569 Serial Number: Vital Sync 3.4.1 CFN: VSLBASE03P / VITALSYNCSW03 UDI-DI (GTIN): 10884521856127 Serial Number: Vital Sync 3.4.2 CFN: VSLBASE04P / VITALSYNCSW04 UDI-DI (GTIN): 10884521849358 Serial Number: Vital Sync 4.0.1 CFN: VSLBASE04P / VITALSYNCSW04 UDI-DI (GTIN): 10884521856134 Serial Number: Vital Sync 4.0.2 Distribution: Worldwide - U.S. Nationwide distribution in the states of AK, AL, AZ, CA, FL, GA, IL, IN, KY, LA, MI, MN, MS, NC, NY, OH, OK, OR, SC, TN, TX, and VA. The country of Spain. Affected quantity: 78 systems
- Hazard
- 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.