Medical device recalls Moderate risk

Getinge (Suzhou) Co Ltd recalls Nimbus 4 and Nimbus Professional Alternating-pressure bed mattress overlay system

Recall date
April 15, 2021
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1788-2021
FDA classification
Class II
Brand / firm
Getinge (Suzhou) Co Ltd
Sold / distributed
USA

Why it was recalled

There is a potential for abnormal inflation of the mattress.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Nimbus 4 and Nimbus Professional Alternating-pressure bed mattress overlay system

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