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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