Recall Z-2605-2016 ยท FNM Mattress, Air Flotation, Alternating Pressure
American National Mfg Inc
Panacea Air Pro Mattress Control Unit, Model: Platinum 5000, US Model Number 5000. Use with alternating pressure air flotation mattress.
| Date | Jul 11, 2016 |
| Status | Terminated |
| Reason | The Panacea Air Pro Mattress Control Unit is being recalled due to a firmware problem, which may result in the device not having the firmness range required. |
| Root cause | Software Manufacturing/Software Deployment |
| Action | An Urgent Medical Device Recall letter, dated 7/11/16, was sent to customers to inform them of a recall involving the Panacea Air Pro Mattress Control Unit also labeled as Platinum 5000, US Model Number 5000, Serial numbers 9500051 through 9500300. The letter informs the customers that the recall has been identified due to firmware problem. The letter informs the customers of the problem identified and the actions to be taken. Customers were asked to immediately examine their inventory and quarantine the affected device. A shipping label would be provided for return and update of the affect |
| Quantity | 31 units |
| Distribution | Distributed to the US -- WI, OH, IL, TX, AZ, MD, IA, PA, CO, WA, ID, MN, LA, WY, and MS. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.