FDAClass IIJune 9, 2021

Nimbus 4 and Nimbus Professional Alternating-pressure recall

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

Why was Nimbus 4 and Nimbus Professional Alternating-pressure recalled?

There is a potential for abnormal inflation of the mattress.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
Nimbus 4 and Nimbus Professional Alternating-pressure bed mattress overlay system
Recalling firm
Getinge (Suzhou) Co Ltd
Quantity
13042 units
Distribution
USA
Recall date
June 9, 2021
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls