Panacea Air Pro Mattress Control Unit, Model: Platinum 5000, US Model Number 5000. Use with alternating pressure air flotation mattress.
This recall has been terminated (originally issued July 11, 2016).
- Company
- American National Mfg Inc
- Recall Initiated
- July 11, 2016
- Terminated
- January 17, 2017
- Recall Number
- Z-2605-2016
- Quantity
- 31 units
- Firm Location
- Corona, CA
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
Distributed to the US -- WI, OH, IL, TX, AZ, MD, IA, PA, CO, WA, ID, MN, LA, WY, and MS.
Lot / Code Info
Serial No. 9500051 sequential to 9500300.
Root Cause
Software Manufacturing/Software Deployment
Action Taken
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 affected devices. All customers that the device was further distributed to would need to be notified of the recall.