FDA recall Z-1788-2021
Getinge (Suzhou) Co Ltd · Class II · device
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.
Distribution
USA
Key facts
- Status
- Terminated
- Initiation date
- 2021-04-15
- Report date
- 2021-06-09
- Termination date
- 2023-11-13
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Suzhou City, China
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1788-2021