Recall Z-2605-2016— American National Mfg Inc

Class II · Terminated

Class II FDA medical device recall by American National Mfg Inc, initiated 2016-07-11, terminated 2017-01-17. FDA's recall record names no specific 510(k) clearance for this event. Product: Panacea Air Pro Mattress Control Unit, Model: Platinum 5000, US Model Number 5000. Use with alternating pressure air flotation mattress.. 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..

Recalling firm
American National Mfg Inc
Classification
Class II
Status
Terminated
Initiated
2016-07-11
Terminated
2017-01-17
Firm location
Corona, CA, United States

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.