Nimbus 4 and Nimbus Professional Alternating-pressure bed mattress overlay system
Recall
- Recall Number
- Z-1788-2021
- Event Number
- 87752
- Firm
- Getinge (Suzhou) Co Ltd NO 158 Fangzhoulu Zhong Xin Gongyeyuanqu Suzhou City China
- FEI Number
- 3005619970
- Product Code
- FNM
- Status
- Terminated
- Root Cause
- Under Investigation by firm
- Initiated
- April 15, 2021
- Terminated
- November 13, 2023
Description
Nimbus 4 and Nimbus Professional Alternating-pressure bed mattress overlay system
There is a potential for abnormal inflation of the mattress.
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.
USA
13042 units