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Recall Observatory FDA recall evidence

Device product

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

Z-2605-2016

July 11, 2016

Class II

Product summary

Firm
American National Mfg Inc
Event
Event 74737
Status
Terminated
Classification
Class II
Quantity
31 units
Official record key
device-enforcement:Z-2605-2016

Official wording

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.

Code information: Serial No. 9500051 sequential to 9500300.

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

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    firmware problem