Pressure IQ Evolve Mattress; Non-powered mattress replacement system. Intended for patients with medium to high risk for
FDA device recall Z-1247-2015 · posted 2015-03-06 · Terminated
Recall details
- Recalling firm
- Arjo Hospital Equipment AB
- Reason for recall
- The firm received complaints regarding multiple mattresses were showing failures resulting in pressure ulcers.
- Action taken
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- IKY
- Quantity affected
- 1,034 units
- Distribution
- Nationwide Distribution.
- Date initiated
- 2014-09-01
- Date posted
- 2015-03-06
- Date terminated
- 2016-01-04
- Location
- Malm¿, Sweden
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.