Device recall
Z-0352-06: ADC Solo & Initia CR 1000, Path Speed CR SP1001, Centricity CR SP1001 and…
FDA device recall · Class II · AGFA Corp.
Key facts
| Recall number (Z-number) | Z-0352-06 |
|---|---|
| Recall event | 34087 |
| Product | ADC Solo & Initia CR 1000, Path Speed CR SP1001, Centricity CR SP1001 and Centricity CR SP 100, image digitizer, components in Agfa''s computed radiography product line. |
| Product code | KPR |
| Recalling firm | AGFA Corp. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 12, 2012 |
| 510(k) numbers | K974597 |
| FEI number | 3001236302 |
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