FDA-Device2015-03-18Class II
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.
Arjo Hospital Equipment AB
Hazard
The firm received complaints regarding multiple mattresses were showing failures resulting in pressure ulcers.
Sold states
Nationwide Distribution.
Affected count
1,034 units
Manufactured in
HANS MICHELSENSGATAN 10, N/A, Malm¿, N/A, Sweden
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1247-2015Don't want to check this manually?
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