FDA Device recall Z-1247-2015
Pressure IQ Evolve Mattress
- FDA Device
- Class II
- terminated
- Published 2015-03-18
On 2015-03-18 the FDA classified a Class II recall of Pressure IQ Evolve Mattress by Arjo Hospital Equipment Ab, citing the firm received complaints regarding multiple mattresses were showing failures resulting in pressure ulcers.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1247-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-09-01 |
| Published | 2015-03-18 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Arjo Hospital Equipment Ab |
| Distribution | US |
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.
Identifiers
| code_info | All Pressure IQ Evolve mattresses equipped with the 60g pods, manufactured January 2012-December 2013. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1247-2015%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.