GE Healthcare MAC VU360 Electrocardiographs
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Moderate risk
Using it may cause temporary or medically reversible health problems. Serious harm is unlikely.
FDA Class II recall · How risk is rated
What happened
Software issue issue with the MAC VU360 v3.0 system. As a result, data from a previous patient may remain on the screen and could be incorrectly associated with a subsequent patient.
From the FDA notice.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Affected if its UDI-DI matches.
GE Healthcare MAC VU360, REF# part number 2030361-023; Electrocardiograph
- UDI-DI
- 00198953107263
Details
- Company began the recall
- Sold in
Worldwide distribution - US Nationwide and the countries of Belgium, Hong Kong, Netherlands, Sweden, UK.
- Event ID
- 99400
- Recall No.
- Z-2876-2026
- Company
- GE Medical Systems Information Technologies IncMilwaukee, Wisconsin
- Hazard
- Software defect
- Quantity recalled
- 163 units
- Recall type
- Voluntary: Firm initiated
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
All recalls from GE Medical Systems Information Technologies Inc
