GE Healthcare MAC VU360 — Class II medical device recall Z-2876-2026
Ongoing recall by GE Medical Systems Information Technologies Inc, reported 2026-08-12, distributed nationwide. Software issue issue with the MAC VU360 v3.0 system. After selecting the order refresh icon, an open preview o
| Recall number | Z-2876-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Medical Systems Information Technologies Inc, Milwaukee, WI, United States |
| Recall initiated | 2026-06-29 |
| Classified | 2026-08-04 |
| Reported by FDA | 2026-08-12 |
| Distributed | Nationwide (US) |
| Countries outside the US | BE, GB, HK, NL, SE |
| Quantity | 163 units |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 00198953107263 |
| Serial numbers | VU219400033SA, VU219400034SA, VU219400045SA, VU219400055SA, VU219490019SA, VU220270027SA, VU220510048SA, VU220510078SA, VU221050014SA, VU221100161SA, VU221100181SA, VU221150078SA, VU221150116SA, VU222120088SA, VU222120212SA, VU222120220SA, VU222120239SA, VU222120243SA, VU222120249SA, VU222120250SA, VU222120253SA, VU222120258SA, VU222120260SA, VU222120261SA, VU222120266SA and 138 more |
| Model numbers | 2030361-023 |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2876-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.