Device recall
Z-2130-2016: The System 83 Plus, Endoscope Washer/Disinfector Designed for the simultaneous…
FDA device recall · Class II · Custom Ultrasonics, Inc.
Key facts
| Recall number (Z-number) | Z-2130-2016 |
|---|---|
| Recall event | 74311 |
| Product | The System 83 Plus, Endoscope Washer/Disinfector Designed for the simultaneous reprocessing of up to two flexible submersible endoscopes that are used in the gastrointestinal and/or pulmonary tracts. |
| Product code | NVE |
| Recalling firm | Custom Ultrasonics, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 18, 2017 |
| 510(k) numbers | K122117 |
| FEI number | 2523209 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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