United StatesCarescape Central Station CSCS V3 MAS800 Desktop (part numbers 5867474-04 and 5867474-13; product code STU) and CSCS V3 MAI800 Integrated (part number 5867474-03; product code STV) from GE Medical Systems Information Technologies are affected and can be recognised by those part numbers and device serial numbers beginning with STU or STV. The devices were recalled because they may not resume patient monitoring for at least 3 minutes after a system restart, which can lead to potential delay in recognition of clinically significant events.
What's being recalled
Carescape Central Station CSCS V3 MAS800 Desktop Part Number 5867474-04, 5867474-13 Product code STU CSCS V3 MAI800 Integrated Part Number 5867474-03 Product Code STV
Recalling firm: GE Medical Systems Information Technologies Inc, Waukesha, WI, United States.
How to identify it
5867474-04 UDI-DI 00195278343512 Device Serial Numbers begin with STU 5867474-13 UDI-DI 00195278516367 Device Serial Numbers begin with STU 5867474-03 UDI-DI 00195278343383 Device Serial Numbers begin with STV
The hazard
Device may not resume patient monitoring for at least 3 minutes following system restart. Issue can lead to potential delay in recognition of clinically significant events.
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 - US Nationwide distribution.
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)