FDA Medical Device Recalls (openFDA)
Getinge (Suzhou) Co Ltd: Nimbus 4 and Nimbus Professional Alternating-pressure bed mattress overlay system
- Recall number
- Z-1788-2021
- Recalling firm
- Getinge (Suzhou) Co Ltd
- Product
- Nimbus 4 and Nimbus Professional Alternating-pressure bed mattress overlay system
- Status
- Terminated
- Initiated
- 2021-04-15
- Posted
- not on file
- Terminated
- 2023-11-13
- Reason
- There is a potential for abnormal inflation of the mattress.
- 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
- 13042 units
- Distribution
- USA
- Lot, serial or model codes
- Model Numbers: 650001ADV, 650001DAR, 650001P, 650201DAR, 651001, 651001ADV, 651001DAR, 651001DARW, 651001P, 651201DAR, 651201P Product Code: 47478 (GMDN nomenclature code)
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FNM
- Firm FEI
- 3005619970
- Firm city
- Suzhou City
- Firm state
- not on file
- Firm country
- China
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28