Class II — GE Medical Systems Information Technologies Inc
| Recalling firm | GE Medical Systems Information Technologies Inc |
|---|---|
| Classification | Class II |
| Status | Ongoing |
| Reason | 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. |
| Product | GE Healthcare MAC VU360, REF# part number 2030361-023; Electrocardiograph |
| Quantity | 163 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of Belgium, Hong Kong, Netherlands, Sweden, UK. |
| Initiated | 2026-06-29 |
| Classified | 2026-08-04 |
| Recall number | Z-2876-2026 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — GE Medical Systems Information Technologies Inc (Z-2876-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/99400/
Alerts for GE Medical Systems Information Technologies Inc
Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.
Want a one-page facility brief?
A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.