Ge Medical Systems Information Technologies Inc: Electrocardiograph
Recall Summary GE Healthcare's MAC VU360 electrocardiograph system has a software issue where preview or review screens may not automatically close after 2 minutes of inactivity. This can leave a previous patient's data visible on the screen, which could be mistakenly linked to the next patient. The affected device (part number 2030361-023) has been distributed across the United States, Belgium, Hong Kong, the Netherlands, Sweden, and the UK.
- Recalling firm
- GE Medical Systems Information Technologies Inc
- Product
- GE Healthcare MAC VU360, REF# part number 2030361-023; Electrocardiograph
- 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.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-06-29
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- Worldwide distribution - US Nationwide and the countries of Belgium, Hong Kong, Netherlands, Sweden, UK.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/5d30466d-2d66-4c86-8a41-d2044f097f23