Z-2605-2016 Class II Terminated
FDA device recall Z-2605-2016 was initiated by American National Mfg Inc on July 11, 2016 and is designated Class II. 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. The recall status is terminated (terminated January 17, 2017). Affected quantity: 31 units.
Recall Details
- Product Type
- Devices
- Report Date
- August 31, 2016
- Initiation Date
- July 11, 2016
- Termination Date
- January 17, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 31 units
Product Description
Panacea Air Pro Mattress Control Unit, Model: Platinum 5000, US Model Number 5000. Use with alternating pressure air flotation mattress.
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 Pattern
Distributed to the US -- WI, OH, IL, TX, AZ, MD, IA, PA, CO, WA, ID, MN, LA, WY, and MS.
Code Information
Serial No. 9500051 sequential to 9500300.