Recall of Device Recall Panacea Air Pro Mattress Control Unit

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by American National Mfg Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
  • Event ID
  • Event Risk Class
    Class 2
  • Event Number
  • Event Initiated Date
  • Event Status
  • Event Country
  • Event Terminated Date
  • Event Source
  • Event Source URL
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Mattress, air flotation, alternating pressure - Product Code FNM
  • 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.
  • 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.


  • Model / Serial
    Serial No. 9500051 sequential to 9500300.
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
    Distributed to the US -- WI, OH, IL, TX, AZ, MD, IA, PA, CO, WA, ID, MN, LA, WY, and MS.
  • Product Description
    Panacea Air Pro Mattress Control Unit, Model: Platinum 5000, US Model Number 5000. || Use with alternating pressure air flotation mattress.
  • Manufacturer


  • Manufacturer Address
    American National Mfg Inc, 252 Mariah Cir, Corona CA 92879-1751
  • Source