Z-1788-2021 Class II Terminated
FDA device recall Z-1788-2021 was initiated by Getinge (Suzhou) Co Ltd on April 15, 2021 and is designated Class II. Reason for recall: There is a potential for abnormal inflation of the mattress. The recall status is terminated (terminated November 13, 2023). Affected quantity: 13042 units.
Recall Details
- Product Type
- Devices
- Report Date
- June 9, 2021
- Initiation Date
- April 15, 2021
- Termination Date
- November 13, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 13042 units
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.
Distribution Pattern
USA
Code Information
Model Numbers: 650001ADV, 650001DAR, 650001P, 650201DAR, 651001, 651001ADV, 651001DAR, 651001DARW, 651001P, 651201DAR, 651201P Product Code: 47478 (GMDN nomenclature code)