Device recall
Z-0852-2015: GETINGE 46-SERIES Medical Washer-Disinfector, Models 46-4 and 46-5, with PACS…
FDA device recall · Class II · Getinge Disinfection Ab
Key facts
| Recall number (Z-number) | Z-0852-2015 |
|---|---|
| Recall event | 69823 |
| Product | GETINGE 46-SERIES Medical Washer-Disinfector, Models 46-4 and 46-5, with PACS 300/350 Control Series with dryer --- Class II, exempt from 510(k) requirements. For use in healthcare facilities and laboratories where reusable items such as instruments, utensils, anesthesia sets, and glassware are… |
| Product code | MEC |
| Recalling firm | Getinge Disinfection Ab |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 12, 2017 |
| FEI number | 3000231474 |
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