Device recall
Z-1084-2016: Mobile wDR motorized portable diagnostic X-ray systems. Intended for use by a…
FDA device recall · Class II · Sedecal S.A.
Key facts
| Recall number (Z-number) | Z-1084-2016 |
|---|---|
| Recall event | 73428 |
| Product | Mobile wDR motorized portable diagnostic X-ray systems. Intended for use by a qualified/trained doctor or technologist on both adult and pediatric patients for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts on both adult and… |
| Product code | IZL |
| Recalling firm | Sedecal S.A. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 7, 2018 |
| 510(k) numbers | K111725 |
| FEI number | 3002495042 |
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