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.
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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