Nimbus 4 and Nimbus Professional Alternating-pressure bed mattress… — Class II medical device recall Z-1788-2021
Terminated recall by Getinge (Suzhou) Co Ltd, reported 2021-06-09. There is a potential for abnormal inflation of the mattress.
| Recall number | Z-1788-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Getinge (Suzhou) Co Ltd, Suzhou City, China |
| Recall initiated | 2021-04-15 |
| Classified | 2021-06-03 |
| Reported by FDA | 2021-06-09 |
| Terminated | 2023-11-13 |
| Quantity | 13,042 units |
| Model numbers | 650001ADV, 650001DAR, 650001P, 650201DAR, 651001, 651001ADV, 651001DAR, 651001DARW, 651001P, 651201DAR, 651201P |
Product
Nimbus 4 and Nimbus Professional Alternating-pressure bed mattress overlay system
Reason for recall
There is a potential for abnormal inflation of the mattress.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1788-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.