Z-1788-2021Class II

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

Name: Z-1788-2021 Nimbus 4 and Nimbus Professional Alternating-pressure bed mattress overlay system
Creator: Getinge (Suzhou) Co Ltd
Published: 2021-04-15
License: https://open.fda.gov/license/

Arjo (Suzhou) Co., Ltd. / initiated 2021-04-15 / Terminated

FDA source

Getinge (Suzhou) Co Ltd began a recall of Nimbus 4 and Nimbus Professional Alternating-pressure bed mattress overlay system on 2021-04-15. FDA classified it as Class II and gives the reason as "There is a potential for abnormal inflation of the mattress". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1788-2021
Classification: Class II
Status: Terminated
Initiated: 2021-04-15
Posted: 2021-06-04
Terminated: 2023-11-13
Recalling firm: Arjo (Suzhou) Co., Ltd.
Product: Nimbus 4 and Nimbus Professional Alternating-pressure bed mattress overlay system
Product code: FNM Mattress, Air Flotation, Alternating Pressure
Reason for recall: There is a potential for abnormal inflation of the mattress.
FDA root cause: Under Investigation by firm
Action: Customers identified as owners of the affected mattresses will be notified of the identified product risk and the Field Safety Corrective Action through the Field Safety Notice. The Field Safety Notice will be accompanied by Customer Response Form. The Field Safety Notice will be accompanied by a video recording. The video demonstrates how to remove the over-inflation risk immediately through puncture of two grommet membranes in the mattress that can be performed on-site. Throughout technical evaluation has confirmed that the puncture of grommet membranes eliminates the patient fall risk and does not introduce any new harm. The customer will be asked to acknowledge the FSN, complete and sign an enclosed Customer Response Form and return it to the local Arjo office (address indicated in the FSN) in order to confirm that the advised activity has been completed following the provided instruction.
Quantity in commerce: 13042 units
Distribution: USA
Product codes and lots: Model Numbers: 650001ADV, 650001DAR, 650001P, 650201DAR, 651001, 651001ADV, 651001DAR, 651001DARW, 651001P, 651201DAR, 651201P Product Code: 47478 (GMDN nomenclature code)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1788-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1788-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-09	2021-06-03

Product code FNM

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)