Device recall
Z-1182-2008: System 83 Plus Washer-Disinfector, Endoscope use, DOS based system, Custom…
FDA device recall · Class II · Custom Ultrasonics, Inc.
Key facts
| Recall number (Z-number) | Z-1182-2008 |
|---|---|
| Recall event | 46877 |
| Product | System 83 Plus Washer-Disinfector, Endoscope use, DOS based system, Custom Ultrasonics Inc., Buckingham, PA |
| Product code | KOG |
| Recalling firm | Custom Ultrasonics, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 3, 2009 |
| 510(k) numbers | K983017 |
| FEI number | 2523209 |
At a glance
- 1–9 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