Device recall
Z-0476-2013: Enterprise 8000 Bed; an AC-powered adjustable hospital bed; ArjoHuntleigh AB…
FDA device recall · Class II · Arjo, Inc. dba ArjoHuntleigh
Key facts
| Recall number (Z-number) | Z-0476-2013 |
|---|---|
| Recall event | 63187 |
| Product | Enterprise 8000 Bed; an AC-powered adjustable hospital bed; ArjoHuntleigh AB, Eslov, Sweden; Models 8000, 8001, 8002, 8003, 8500, 8600, 8700 and 8800 General medicine, general and specialist surgery, care of the elderly, HDU, ITU, coronary care and oncology. The bed is appropriate for high… |
| Product code | FNL |
| Recalling firm | Arjo, Inc. dba ArjoHuntleigh |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 13, 2016 |
| FEI number | 1419652 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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