Device recall
Z-0866-2017: Insufflator, laparoscopic The ConMed GS2000, Smith & Nephew 500, Novadaq 50L and…
FDA device recall · Class II · Northgate Technologies, Inc.
Key facts
| Recall number (Z-number) | Z-0866-2017 |
|---|---|
| Recall event | 75716 |
| Product | Insufflator, laparoscopic The ConMed GS2000, Smith & Nephew 500, Novadaq 50L and Nebulae I insufflators are devices that provide CO2 gas distention of surgical cavities for diagnostic and/or operative endoscopy. The insufflator has multiple operating modes which can be used for the following… |
| Product code | HIF |
| Recalling firm | Northgate Technologies, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 27, 2017 |
| 510(k) numbers | K120151 |
| FEI number | 1450997 |
At a glance
- 1–9 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