The Recall Desk
ModerateFDA (Devices)·Z-2605-2016·Announced 2016-08-31

Panacea Air Pro Mattress Control Unit Recalled for Firmware Issue

American National Mfg Inc is recalling 31 Panacea Air Pro Mattress Control Units due to a firmware problem that may affect the device's firmness range.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity score.

Plain-English summary

American National Mfg Inc is recalling 31 units of the Panacea Air Pro Mattress Control Unit, Model Platinum 5000 (US Model Number 5000). The recall is due to a firmware problem that may result in the device not having the required firmness range. These units are used with alternating pressure air flotation mattresses.

The affected units have serial numbers ranging sequentially from 9500051 to 9500300. The products were distributed to the United States, specifically in the states of Wisconsin, Ohio, Illinois, Texas, Arizona, Maryland, Iowa, Pennsylvania, Colorado, Washington, Idaho, Minnesota, Louisiana, Wyoming, and Mississippi.

Consumers should stop using the affected units and contact the recalling firm for instructions on how to proceed with the recall.

The recalled product

Product
Panacea Air Pro Mattress Control Unit, Model: Platinum 5000, US Model Number 5000. Use with alternating pressure air flotation mattress.
Manufacturer
American National Mfg Inc
Category
Medical Device — Mattress Control Unit
Hazard
Affected units
31

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Serial No. 9500051 sequential to 9500300.

Distribution

Distributed in 15 states:

Related recalls

Same hazard · firmware defect

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