FDA Device

Pressure IQ Evolve Mattress; Non-powered mattress replacement system. Intended for patients with medium to high risk for developing pressure ulcers while on a mattress.

Hazard

The firm received complaints regarding multiple mattresses were showing failures resulting in pressure ulcers.

What You Should Do

Remedy

On 9/1/14 the recalling firm sent out a letter to their customers notifying them of an updated IFU for the recalled device. The letter also requested the customers to verify the quantity of the product they currently have on hand.

Products

Pressure IQ Evolve Mattress; Non-powered mattress replacement system. Intended for patients with medium to high risk for developing pressure ulcers while on a mattress.
Brand
Arjo Hospital Equipment AB HANS MICHELSENSGATAN
UPC
All Pressure IQ Evolve mattresses equipped with the 60g pods, manufactured January 2012-December 2013.

Units Affected

1,034 units