Recall Z-1788-2021 ยท FNM Mattress, Air Flotation, Alternating Pressure
Getinge (Suzhou) Co Ltd
Nimbus 4 and Nimbus Professional Alternating-pressure bed mattress overlay system
| Date | Apr 15, 2021 |
| Status | Terminated |
| Reason | There is a potential for abnormal inflation of the mattress. |
| Root cause | Under Investigation by firm |
| Action | 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 an |
| Quantity | 13042 units |
| Distribution | USA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.