Device recall
Z-0652-03: Optima URS X-Ray System; Manufactured by SEDECAL, C/Pelya 9 Pol. Ind. Rio De…
FDA device recall · Class II · Sedecal USA, Inc.
Key facts
| Recall number (Z-number) | Z-0652-03 |
|---|---|
| Recall event | 26111 |
| Product | Optima URS X-Ray System; Manufactured by SEDECAL, C/Pelya 9 Pol. Ind. Rio De Janeiro, 28110 Algete (Madrid) SPAIN |
| Product code | KPR-- |
| Recalling firm | Sedecal USA, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 29, 2005 |
| 510(k) numbers | K012546 |
| FEI number | 1000139935 |
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