FDA DeviceClass IINotable

FDA Recall: GE Healthcare MAC VU360, REF# part number 2030361-023; Electrocardiograph

Date: 2026-08-12
Brand: GE Medical Systems Information Technologies Inc
Category: Medical Device
FDA Class: Class II

Description

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.

Hazard

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.

Remedy

163 units

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