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Terminated

Panacea Air Pro Mattress Control Unit, Model: Platinum 5000, US Model Number 5000. Use with alternating pressure air flotation mattress.

FDA Recall Z-2605-2016 · Posted None

Recalling FirmAmerican National Mfg Inc
Recall StatusTerminated
Product CodeFNM
Date Initiated2016-07-11
Date Terminated2017-01-17
Product Quantity31 units

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.

Firm 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.

Root Cause

Software Manufacturing/Software Deployment

Distribution Pattern

Distributed to the US -- WI, OH, IL, TX, AZ, MD, IA, PA, CO, WA, ID, MN, LA, WY, and MS.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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