RecallRadar

FDA Device recall Z-1788-2021

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

On 2021-06-09 the FDA classified a Class II recall of Nimbus 4 and Nimbus Professional Alternating-pressure bed mattress overlay system by Getinge Suzhou, citing there is a potential for abnormal inflation of the mattress.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1788-2021
ClassificationClass II
Statusterminated
Initiated2021-04-15
Published2021-06-09
Last updated2026-09-13 11:56 UTC
CompanyGetinge Suzhou
Distributionn/a

Product

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

Reason

There is a potential for abnormal inflation of the mattress.

Identifiers

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

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1788-2021%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.