GE Healthcare MAC VU360 ECG recalled for patient data mix-up risk
GE Healthcare recalled certain MAC VU360 electrocardiograph units running software v3.0. After the order refresh icon is selected, a preview or review screen may not close automatically after 2 minutes of inactivity, so data from a previous patient could stay on screen and be linked to the next patient. No injuries have been reported.
From the FDA notice · Read the official notice ↗ · All GE recalls
What to do
- Check whether your MAC VU360 serial number appears on the recall list.
- Contact GE Healthcare for guidance on the software issue, since this notice lists no specific remedy.
- Manually close any open preview or review screen before using the device with a new patient.
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- GE Healthcare MAC VU360, REF# part number 2030361-023; Electrocardiograph
- Sold in
- Nationwide
- Made for
- All ages (0 months and older)
Details
- Units affected
- 163 units
- Illnesses reported
- None reported
- Manufactured in
- 9900 W Innovation Dr, Milwaukee, WI, United States
- Classification
- Class II
- Recall number
- Z-2876-2026
In the FDA's words
- Description
- GE Healthcare MAC VU360, REF# part number 2030361-023; Electrocardiograph 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. 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, VU222120088SA, VU223130071SA, VU223220135SA, VU223220174SA, VU219490019SA, VU226050047SA, VU225460222SA, VU225460237SA, VU225470012SA, VU225470018SA, VU225470022SA, VU225470023SA, VU225470024SA, VU225470030SA, VU225470034SA, VU225470035SA, VU225470038SA, VU221050014SA, VU223310039SA, VU223450002SA, VU223310012SA, VU222190155SA, VU225060039SA, VU225060040SA, VU225060046SA, VU225060038SA, VU226154224SA, VU225500096SA, VU225500106SA, VU225500109SA, VU225500019SA, VU225500031SA, VU225500076SA. Distribution: Worldwide distribution - US Nationwide and the countries of Belgium, Hong Kong, Netherlands, Sweden, UK. Affected quantity: 163 units
- 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.
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