GE Healthcare MAC VU360 Electrocardiograph Software Recall
GE Healthcare is recalling 163 MAC VU360 electrocardiograph units due to a software issue that may cause a previous patient's data to remain visible and be incorrectly associated with a subsequent patient.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class II recall. Per the rubric, FDA Class II recalls with potential for patient data misassociation affecting medical device operation warrant a score of 4 (Severe).
Plain-English summary
GE Medical Systems Information Technologies Inc is recalling 163 units of the GE Healthcare MAC VU360 electrocardiograph (REF# 2030361-023) due to a software issue in 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 recall affects units distributed worldwide, including US nationwide distribution and the countries of Belgium, Hong Kong, Netherlands, Sweden, and the UK. The affected units are identified by GTIN 00198953107263 and specific serial numbers listed in the recall notice.
This is an FDA Class II recall, meaning the issue could cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. No deaths or serious injuries have been reported in connection with this issue.
Healthcare facilities and users should contact GE Healthcare for instructions on software updates or corrective actions. Consumers or patients with questions should consult their healthcare provider.
The recalled product
- Product
- GE Healthcare MAC VU360, REF# part number 2030361-023; Electrocardiograph
- Manufacturer
- GE Medical Systems Information Technologies Inc
- Affected units
- 163
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- GTIN 00198953107263
- Serial Numbers: VU221150078SA
- VU222400121SA
- VU223230048SA
- VU222520132SA
- VU219400033SA
- VU219400034SA
- VU219400045SA
- VU219400055SA
- VU220270027SA
- VU220510048SA
- VU220510078SA
- VU221100161SA
- VU221100181SA
- VU221150116SA
- VU222120212SA
- VU222120220SA
- VU222120239SA
- VU222120243SA
- VU222120249SA
Distribution
Distributed nationwide across the United States.
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