Device recall
Z-1216-2010: AccuMax Quantum Complete (Model CU3/CU4), an alternating pressure with turn…
FDA device recall · Class II · Encompass Therapeutic Support Systems dba BG North America
Key facts
| Recall number (Z-number) | Z-1216-2010 |
|---|---|
| Recall event | 55074 |
| Product | AccuMax Quantum Complete (Model CU3/CU4), an alternating pressure with turn assist & on demand low air loss system; Encompass Therapuetic Support Systems, Glendale, CA. The device is intended to treat or prevent decubitus ulcers, extensive burns, urinary tract blockage and to aid circulation. |
| Product code | FNM |
| Recalling firm | Encompass Therapeutic Support Systems dba BG North America |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 21, 2012 |
| FEI number | 3002468793 |
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