Device recall
Z-1216-2013: KARL STORZ Photodynamic Diagnosis (PDD) D-Light C System, Instruction Manuals…
FDA device recall · Class II · Karl Storz Endoscopy America Inc
Key facts
| Recall number (Z-number) | Z-1216-2013 |
|---|---|
| Recall event | 60555 |
| Product | KARL STORZ Photodynamic Diagnosis (PDD) D-Light C System, Instruction Manuals: PDD Telescopes, Tricam SL II, and PDD Camera Heads. Used as an optional accessory to white light cystoscopy when used in combination with the diagnostic imaging drug Cysview. |
| Product code | OAY |
| Recalling firm | Karl Storz Endoscopy America Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 8, 2013 |
| FEI number | 2020550 |
At a glance
- None 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