Device recall
Z-0047-04: Brand name: Olympus ImageManager Software, Versions 6.0 through 6.4.1 (excluding…
FDA device recall · Class II · Olympus America Inc.
Key facts
| Recall number (Z-number) | Z-0047-04 |
|---|---|
| Recall event | 27169 |
| Product | Brand name: Olympus ImageManager Software, Versions 6.0 through 6.4.1 (excluding version 6.3.8) Common name: Medical image storage device. Class I, 510 (k) exempt. (NOTE: any ImageManager Software sold as a stand-alone system is not impacted by this software malfunction since no opportunity exists… |
| Product code | LMB |
| Recalling firm | Olympus America Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 22, 2005 |
| 510(k) numbers | K934888, K934889 |
| FEI number | 2429304 |
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