Pressure IQ Evolve Mattress — Class II medical device recall Z-1247-2015
Terminated recall by Arjo Hospital Equipment AB, reported 2015-03-18, distributed nationwide. The firm received complaints regarding multiple mattresses were showing failures resulting in pressure ulcers.
| Recall number | Z-1247-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Arjo Hospital Equipment AB, Malm¿, N/A, Sweden |
| Recall initiated | 2014-09-01 |
| Classified | 2015-03-06 |
| Reported by FDA | 2015-03-18 |
| Terminated | 2016-01-04 |
| Distributed | Nationwide (US) |
| Quantity | 1,034 units |
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 for recall
The firm received complaints regarding multiple mattresses were showing failures resulting in pressure ulcers.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1247-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.