Device recall
Z-0534-2021: Shimadzu Mobile X-Ray System, MobileDaRt Evolution (MX8 Version), with…
FDA device recall · Class II · Shimadzu Medical Systems
Key facts
| Recall number (Z-number) | Z-0534-2021 |
|---|---|
| Recall event | 86734 |
| Product | Shimadzu Mobile X-Ray System, MobileDaRt Evolution (MX8 Version), with adjustable handle option, Made in Japan - Product Usage: The device is intended to be used to take a film, CR or general radiography of patients in the hospital who cannot move and/or of outpatients in emergency. |
| Product code | IZL |
| Recalling firm | Shimadzu Medical Systems |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K080701 |
| FEI number | 1000125362 |
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