United StatesThe recall affects the GE Healthcare MAC VU360 electrocardiograph (REF# part number 2030361-023, GTIN 00198953107263) running MAC VU360 v3.0; affected units include 163 devices with specific serial numbers listed by the firm. The device was recalled because a software issue can leave prior patient data visible after selecting the order refresh icon, potentially causing data from a previous patient to be incorrectly associated with a subsequent patient.
What's being recalled
GE Healthcare MAC VU360, REF# part number 2030361-023; Electrocardiograph
Recalling firm: GE Medical Systems Information Technologies Inc, Milwaukee, WI, United States.
How to identify it
GTIN 00198953107263, Serial Numbers: VU221150078SA, VU222400121SA, VU223230048SA, VU222520132SA, VU219400033SA, VU219400034SA, VU219400045SA, VU219400055SA, VU220270027SA, VU220510048SA, VU220510078SA, VU221100161SA, VU221100181SA, VU221150116SA, VU222120212SA, VU222120220SA, VU222120239SA, VU222120243SA, VU222120249SA, VU222120250SA, VU222120253SA, VU222120258SA, VU222120260SA, VU222120261SA, VU222120266SA, VU222120269SA, VU222140004SA, VU222200296SA, VU222520114SA, VU223120014SA, VU223120041SA, VU223420119SA, VU224050158SA, VU224070091SA, VU224200028SA, VU224420159SA, VU224520140SA, VU225170260SA, VU225420050SA, VU225520037SA, VU226040025SA, VU419320042SA, VU421490135SA, VU421490151SA, VU421490153SA, VU421490155SA, VU421490159SA, VU422460150SA, VU422460194SA, VU422460203SA, VU422460303SA, VU422480164SA, VU422500239SA, VU422500240SA, VU422500241SA, VU422500242SA, VU422500244SA, VU422500245SA, VU422500246SA, VU422500247SA, VU422500248SA, VU422500249SA, VU422500250SA, VU422500251SA, VU422500254SA, VU422500260SA, VU422500261SA, VU422500264SA, VU422500265SA, VU422500266SA, VU422500267SA, VU422500269SA, VU422510038SA, VU422510049SA, VU422510060SA, VU422510061SA, VU423050080SA, VU423050178SA, VU423220064SA, VU423220225SA, VU425130020SA, VU425130022SA, VU425130024SA, VU425130084SA, VU425130085SA, VU421490060SA, VU421490063SA, VU421490065SA, VU421490068SA, VU421490069SA, VU421490097SA, VU421490122SA, VU422460206SA, VU422460209SA, VU422460215SA, VU422460218SA, VU422460219SA, VU422460302SA, VU422460304SA, VU422460269SA, VU422460273SA, VU422460274SA, VU422460278SA, VU422460282SA, VU422460284SA, VU422480071SA, VU422460306SA, VU422460285SA, VU422480070SA, VU422460287SA, VU422460301SA, VU422480066SA, VU422480078SA, VU422480083SA, VU422480084SA, VU422480085SA, VU422480086SA, VU422480087SA, VU422480088SA, VU422480099SA, VU422480110SA, VU422480111SA, VU422480120SA, VU422480121SA, VU422480125SA, VU422480127SA, VU422480128SA, VU422480129SA, VU425130087SA, VU224200105SA…
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.
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 distribution - US Nationwide and the countries of Belgium, Hong Kong, Netherlands, Sweden, UK.
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)