Device recall
Z-0862-06: REGIUS Image Manager (AKA REGIUS IM, RIM). Catalogue Number 5900554. Centralized…
FDA device recall · Class II · Konica Minolta Medical Imaging USA, Inc.
Key facts
| Recall number (Z-number) | Z-0862-06 |
|---|---|
| Recall event | 34785 |
| Product | REGIUS Image Manager (AKA REGIUS IM, RIM). Catalogue Number 5900554. Centralized CR Image Quality Control. Patient throughput optimization via offloaded processing from various CR readers. Technologist review and audit. Key processing for specialized exams, totally automated processing for hands off… |
| Product code | LLZ |
| Recalling firm | Konica Minolta Medical Imaging USA, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 22, 2008 |
| 510(k) numbers | K051523 |
| FEI number | 2241281 |
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