Device recall
Z-1247-2015: Pressure IQ Evolve Mattress; Non-powered mattress replacement system. Intended…
FDA device recall · Class II · Arjo Hospital Equipment AB
Key facts
| Recall number (Z-number) | Z-1247-2015 |
|---|---|
| Recall event | 68235 |
| 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. |
| Product code | IKY |
| Recalling firm | Arjo Hospital Equipment AB |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 4, 2016 |
| FEI number | 3002806395 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database