Z-2876-2026 Class II Ongoing
FDA device recall Z-2876-2026 was initiated by GE Medical Systems Information Technologies Inc on June 29, 2026 and is designated Class II. Reason for recall: 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 res… The recall status is ongoing. Affected quantity: 163 units.
Recall Details
- Product Type
- Devices
- Report Date
- August 12, 2026
- Initiation Date
- June 29, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 163 units
Product Description
GE Healthcare MAC VU360, REF# part number 2030361-023; Electrocardiograph
Reason for Recall
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.
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of Belgium, Hong Kong, Netherlands, Sweden, UK.
Code Information
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.