Device recall
Z-0261-2013: R-20J, Diagnostic X-Ray Beam-Limiting Device. In combination with any of below…
FDA device recall · Class II · Shimadzu Medical Systems
Key facts
| Recall number (Z-number) | Z-0261-2013 |
|---|---|
| Recall event | 62271 |
| Product | R-20J , Diagnostic X-Ray Beam-Limiting Device. In combination with any of below X-Ray tubes: 06/1.2P364DK-85, 0.6/1.2P324DK-125, 06/1.2P324DK-85, 0.6/1.2P38DE-85. Product Usage: The device is the beam-limiting device for X-ray Radiography. |
| Product code | IZX |
| Recalling firm | Shimadzu Medical Systems |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 26, 2016 |
| 510(k) numbers | K101036 |
| FEI number | 1000125362 |
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