Recall Z-2876-2026 ยท DPS Electrocardiograph
GE Medical Systems Information Technologies Inc
GE Healthcare MAC VU360, REF# part number 2030361-023; Electrocardiograph
| Date | Aug 4, 2026 (initiated Jun 29, 2026) |
| Status | Open, Classified |
| 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. |
| Root cause | Software design |
| Action | GE Healthcare issued an URGENT MEDICAL DEVICE CORRECTION notice to its consignees on 6/29/2026 via US mail. The notice explained the issue, potential risk, and requested the following: 'Actions to be taken by Customer/User You can continue to use your device. Pending corrections from GE HealthCare, after pressing the Order Refresh icon do not rely on automatic closure of the Preview and or Review screen when: " patient has been disconnected, and " at least 2 minutes of system inactivity If this occurs, do the following to clear all patient information data: " On the Preview screen, selec |
| Quantity | 163 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of Belgium, Hong Kong, Netherlands, Sweden, UK. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K173830 | MAC VU360 Resting ECG Analysis System Ge Medical Systems Information Technologies, Inc., Sep 18, 2018 |