Medical device recalls Moderate risk

Arjo Hospital Equipment AB recalls Pressure IQ Evolve Mattress; Non-powered mattress replacement system. Intended for patients with medium to high risk fo…

Recall date
September 1, 2014
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1247-2015
FDA classification
Class II
Brand / firm
Arjo Hospital Equipment AB
Sold / distributed
Nationwide Distribution.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.

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