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U.S. Department of Health and Human Services

Class 2 Device Recall Panacea Air Pro Mattress Control Unit

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  Class 2 Device Recall Panacea Air Pro Mattress Control Unit see related information
Date Initiated by Firm July 11, 2016
Create Date August 19, 2016
Recall Status1 Terminated 3 on January 17, 2017
Recall Number Z-2605-2016
Recall Event ID 74737
Product Classification Mattress, air flotation, alternating pressure - Product Code FNM
Product Panacea Air Pro Mattress Control Unit, Model: Platinum 5000, US Model Number 5000.

Use with alternating pressure air flotation mattress.
Code Information Serial No. 9500051 sequential to 9500300.
Recalling Firm/
Manufacturer
American National Mfg Inc
252 Mariah Cir
Corona CA 92879-1751
For Additional Information Contact
800-854-6295
Manufacturer 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.
FDA Determined
Cause 2
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 affected devices. All customers that the device was further distributed to would need to be notified of the recall.
Quantity in Commerce 31 units
Distribution Distributed to the US -- WI, OH, IL, TX, AZ, MD, IA, PA, CO, WA, ID, MN, LA, WY, and MS.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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