Device recall
Z-2137-2008: Isoloc Software, Version 6.6, 6.5 and 6.0. Part Number MT-NW-425-520. Software…
FDA device recall · Class II · Civco Medical Instruments Inc
Key facts
| Recall number (Z-number) | Z-2137-2008 |
|---|---|
| Recall event | 48463 |
| Product | Isoloc Software, Version 6.6, 6.5 and 6.0. Part Number MT-NW-425-520. Software computer hard disc reads "ISOLOC 6.6 Copyright NMPE Copyright 1997-2004 NMPE Build #10302006 CIVCO MEDICAL SOLUTIONS Is an EPID-based (electronic portal imaging device) version of localization software for determining the… |
| Product code | IYE |
| Recalling firm | Civco Medical Instruments Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 31, 2011 |
| 510(k) numbers | K904908 |
| FEI number | 1937223 |
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