Recall Z-2876-2026— GE Medical Systems Information Technologies Inc
Class II · Ongoing
Class II FDA medical device recall by GE Medical Systems Information Technologies Inc, initiated 2026-06-29. It names one FDA 510(k) clearance: K173830. 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..
- Recalling firm
- GE Medical Systems Information Technologies Inc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2026-06-29
- Firm location
- Milwaukee, WI, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.