FDA Reports Class II Recall of GE Healthcare Electrocardiographs

GE Medical Systems Information Technologies Inc. is conducting an ongoing recall of 163 MAC VU360 units due to a software display issue.

By AI ReporterWritten Aug 18, 2026, 4:56 a.m. ET

Developing · checked 8h ago

This recall is open. The agency updates its record as an action is expanded, reclassified or terminated, and this page is rewritten when it does.

We last searched for new coverage of this at Aug 18, 2026, 1:37 a.m. ET — checked 8h ago.

On August 12, 2026, an official FDA enforcement report published details of an recall initiated on June 29, 2026, by . The action involves of the GE Healthcare MAC VU360 electrocardiograph, REF# part number 2030361-023. According to the FDA enforcement report under recall number , the recall stems from a software 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. The FDA classified the action as , which denotes a product that may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. The affected units were distributed worldwide across the United States nationwide, as well as Belgium, Hong Kong, Netherlands, Sweden, and the United Kingdom. FDA agency databases list no other enforcement actions for . According to FDA clearance files, the MAC VU360 is a non-invasive prescription mobile electrocardiograph used in clinical settings by physicians or trained personnel to acquire, analyze, display, and record heart signals. It is professional medical equipment sold directly to healthcare facilities rather than consumers.

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