United StatesThe HealthCast “Vital Sync” Remote Patient Monitoring System is affected; identified as Product Numbers VSLBASE03P/VITALSYNCSW03 and VSLBASE04P/VITALSYNCSW04 (models Vital Sync 3.3.1, 3.4.0, 3.4.1 (OUS), 3.4.2, 4.0.0, 4.0.2; UDI‑DI codes 10884521844933, 10884521844940, 10884521847569, 10884521856127, 10884521849358, 10884521856134). It was recalled after complaints and investigations found alarms from the primary bedside monitor were not alarming or being transmitted and received on the remote patient monitoring system.
What's being recalled
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…
Recalling firm: Covidien LLC, Boulder, CO, United States.
How to identify it
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
The 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.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
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.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)
Canada