Device recall
Z-0213-2012: DICOM Option for the Norland Illuminatus Software Revs 4.2.0 though 4.3.1…
FDA device recall · Class II · Cooper Surgical, Inc.
Key facts
| Recall number (Z-number) | Z-0213-2012 |
|---|---|
| Recall event | 60101 |
| Product | DICOM Option for the Norland Illuminatus Software Revs 4.2.0 though 4.3.1. Models Norland XR-600, XR-800, XR-46, EXCELL, XR-36 and Eclipse DXA Bone Densitometers. The XR 46 performs DXA scans of the AP Spine, Hip, Forearm, Lateral Spine, and Whole Body, as well as other user selectable sites. It… |
| Product code | KGI |
| Recalling firm | Cooper Surgical, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 9, 2013 |
| 510(k) numbers | K992125 |
| FEI number | 1216677 |
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