Device recall
Z-1391-2020: Getinge 46-Series Washer Disinfector Model # 46-4, Part Number:46-4-503 Product…
FDA device recall · Class III · Maquet Cardiovascular Us Sales, Llc
Key facts
| Recall number (Z-number) | Z-1391-2020 |
|---|---|
| Recall event | 84885 |
| Product | Getinge 46-Series Washer Disinfector Model # 46-4, Part Number:46-4-503 Product Usage: Used in facilities such as Central Sterile Supply Departments, next to the Operating Room, in dental clinics or hospital wards to clean, thermally or chemically disinfect and dry surgical goods. |
| Product code | MEC |
| Recalling firm | Maquet Cardiovascular Us Sales, Llc |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Oct 23, 2023 |
| FEI number | 3013876692 |
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