CLASS II Device recall · Reported 9 Jun 2021 · FDA Enforcement Report

Nimbus 4 and Nimbus Professional Alternating-pressure bed recalled

Getinge (Suzhou) Co is recalling Nimbus 4 and Nimbus Professional Alternating-pressure bed mattress overlay system. The recall was initiated on 15 Apr 2021 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel Numbers: 650001ADV, 650001DAR, 650001P, 650201DAR, 651001, 651001ADV, 651001DAR, 651001DARW, 651001P, 651201DAR, 651201P Product Code: 47478 (GMDN nomenclature code)

Quantity recalled13042 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1788-2021
FDA event ID: 87752
Recalling firm: Getinge (Suzhou) Co, Suzhou City
Classification: Class II
Status: Terminated
Recall initiated: 15 Apr 2021
FDA classified: 3 Jun 2021
Reported: 9 Jun 2021
Type: Voluntary: Firm initiated
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

15 Apr 2021	Recall initiated by company
3 Jun 2021	Classified by FDA	+49 days
9 Jun 2021	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

There is a potential for abnormal inflation of the mattress.

Product as listed by the FDA

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

Where it was distributed

USA

Questions about this recall

Why was it recalled?

There is a potential for abnormal inflation of the mattress.

Which lots are affected?

Model Numbers: 650001ADV, 650001DAR, 650001P, 650201DAR, 651001, 651001ADV, 651001DAR, 651001DARW, 651001P, 651201DAR, 651201P Product Code: 47478 (GMDN nomenclature code)

Where was it sold?

USA

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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