GE Healthcare MAC VU360, REF# part number 2030361-023; Electrocardiograph
GE Medical Systems Information Technologies Inc
The hazard
Software issue issue with the MAC VU360 v3.0 system. After selecting the order refresh icon, an open preview or review screen might fail to close automatically after 2 minutes of inactivity. As a result, data from a previous patient may remain on the screen and could be incorrectly associated with a subsequent patient. FDA Class II recall.
The remedy
Follow FDA guidance
About this recall
GE Healthcare MAC VU360, REF# part number 2030361-023; Electrocardiograph
Affected identifiers
Check these against the label on your unit. An identifier match is how a recall is confirmed, not just suspected.
Model GTIN 00198953107263Model Serial Numbers: VU221150078SAModel VU222400121SAModel VU223230048SAModel VU222520132SAModel VU219400033SAModel VU219400034SAModel VU219400045SAModel VU219400055SAModel VU220270027SAModel VU220510048SAModel VU220510078SAModel VU221100161SAModel VU221100181SAModel VU221150116SAModel VU222120212SAModel VU222120220SAModel VU222120239SAModel VU222120243SAModel VU222120249SAModel VU222120250SAModel VU222120253SAModel VU222120258SAModel VU222120260SAModel VU222120261SAUPC 00198953107263Would you have heard about this one?
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