Recall Z-1247-2015 ยท IKY Mattress, Flotation Therapy, Non-Powered
Arjo Hospital Equipment AB
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.
| Date | Mar 6, 2015 (initiated Sep 1, 2014) |
| Status | Terminated |
| Reason | The firm received complaints regarding multiple mattresses were showing failures resulting in pressure ulcers. |
| Root cause | Device Design |
| Action | 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. |
| Quantity | 1,034 units |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.