Recall Z-1788-2021— Getinge (Suzhou) Co Ltd
Class II · Terminated
Class II FDA medical device recall by Getinge (Suzhou) Co Ltd, initiated 2021-04-15, terminated 2023-11-13. FDA's recall record names no specific 510(k) clearance for this event. Product: Nimbus 4 and Nimbus Professional Alternating-pressure bed mattress overlay system. Reason: There is a potential for abnormal inflation of the mattress..
- Recalling firm
- Getinge (Suzhou) Co Ltd
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-04-15
- Terminated
- 2023-11-13
- Firm location
- Suzhou City, China
Product description
Nimbus 4 and Nimbus Professional Alternating-pressure bed mattress overlay system
Reason for recall
There is a potential for abnormal inflation of the mattress.
Data sourced from openFDA. This site is unofficial and independent of the FDA.