Recall Z-1247-2015— Arjo Hospital Equipment AB
Class II · Terminated
Class II FDA medical device recall by Arjo Hospital Equipment AB, initiated 2014-09-01, terminated 2016-01-04. FDA's recall record names no specific 510(k) clearance for this event. Product: 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.. Reason: The firm received complaints regarding multiple mattresses were showing failures resulting in pressure ulcers..
- Recalling firm
- Arjo Hospital Equipment AB
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-09-01
- Terminated
- 2016-01-04
- Firm location
- Malm¿, N/A, Sweden
Product description
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.
Reason for recall
The firm received complaints regarding multiple mattresses were showing failures resulting in pressure ulcers.
Data sourced from openFDA. This site is unofficial and independent of the FDA.