Device recall
Z-0727-03: ICON 9.5 Software used on the ICON workstations designed for use with the E.CAM…
FDA device recall · Class III · Siemens Medical Solutions USA, Inc.
Key facts
| Recall number (Z-number) | Z-0727-03 |
|---|---|
| Recall event | 25541 |
| Product | ICON 9.5 Software used on the ICON workstations designed for use with the E.CAM Emission Imaging Computed Tomography Systems; Siemens Medical Systems, Inc., Nuclear Medicine Group, Hoffman Estates, IL 60195-5203 |
| Product code | JWM |
| Recalling firm | Siemens Medical Solutions USA, Inc. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Jan 19, 2005 |
| 510(k) numbers | K903315, K914350 |
| FEI number | 1000514697 |
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