International safety notice
General name: Stationary digital general-purpose X-ray diagnostic device Sales name: (1) Diagnostic X-ray device RADspeed Pro (2) Diagnostic X-ray device DR-DX101 (3) Diagnostic X-ray device FUJIFILM DR BENEO-Fx
Japan / PMDA Recalls · JPN · Jul 25, 2025
Key facts
| Regulator | Japan / PMDA Recalls |
|---|---|
| Country | JPN |
| Brand | General name: Stationary digital general-purpose X-ray diagnostic device Sales name: (1) Diagnostic X-ray device RADspeed Pro (2) Diagnostic X-ray device DR-DX101 (3) Diagnostic X-ray device FUJIFILM DR BENEO-Fx |
| Manufacturer | Shimadzu Corporation |
| Models | 41F138CEB001, 41F138CE8005, 41F138CEC001, MP95AD0EB001, 41F138CEC006, 41F138CEB004, 41F138CE9003, 41F138CE8003, 416FD47EC001, 41F138CE8008, MP95AD0E8001, 416FD48EB001 and 32 more |
| Date | Jul 25, 2025 |
| Regulator page | info.pmda.go.jp |
At a glance
- No Recall
- No Field safety notice
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About International device safety notices
Field safety notices, recalls and safety alerts published by about 30 national medical device regulators outside the United States, matched by Orca1 to FDA device data.
Source: National medical device regulators (as listed), compiled by Orca1