International safety notice
General names: (1) to (5) Stationary digital general-purpose X-ray diagnostic device, (6) to (11) Stationary digital general-purpose X-ray fluoroscopy diagnostic device, (12) to (14) Stationary digital circulatory fluoroscopy diagnostic device, (15) Synchronizer for radiation therapy devices, (16)~(22) X-ray induced arithmetic device for diagnosis according to the type Sales name: (1) Digital X-ray general imaging system RADspeed safire (2) Diagnostic X-ray device RADspeed Pro (3) Digital X-ray general imaging system DR-XD 100 (4) Diagnostic X-ray device DR-XD 101 (5) Diagnostic X-ray device FUJIFILM DR BENEO-Fx (6)X-ray TV system SONIALVISION G4 (7)X-ray TV system SONIALVISION safire17 (8)X-ray TV system SONIALVISION VERSA 100 (9)X-ray TV system SONIALVISION VERSA 100R (10)X-ray TV system FLEXAVISION (11) Cassettele X-ray TV System SHIMAVISION EX Pro (12) Angiography System Trinias (13) Angiography System BRANSIST safire (14) Angiography System Partire α (15) SyncTraX Motion Tracking System for Radiation Therapy Devices (16) Diagnostic X-ray high voltage device UD150B-40 (17) Diagnostic X-ray high voltage device UD150B-40SPT (18) Diagnostic X-ray high voltage device UD150G-40 (19) Diagnostic X-ray high voltage device UD150L-40 (20) Diagnostic X-ray High Voltage Device UD150L-40E (21) Diagnostic X-ray high voltage device UD150L-40F (22) Diagnostic X-ray high voltage device XUD150L-40F
Japan / PMDA Recalls · JPN · Jun 30, 2025
Key facts
| Regulator | Japan / PMDA Recalls |
|---|---|
| Country | JPN |
| Brand | General names: (1) to (5) Stationary digital general-purpose X-ray diagnostic device, (6) to (11) Stationary digital general-purpose X-ray fluoroscopy diagnostic device, (12) to (14) Stationary digital circulatory fluoroscopy diagnostic device, (15) Synchronizer for radiation therapy devices, (16)~(22) X-ray induced arithmetic device for diagnosis according to the type Sales name: (1) Digital X-ray general imaging system RADspeed safire (2) Diagnostic X-ray device RADspeed Pro (3) Digital X-ray general imaging system DR-XD 100 (4) Diagnostic X-ray device DR-XD 101 (5) Diagnostic X-ray device FUJIFILM DR BENEO-Fx (6)X-ray TV system SONIALVISION G4 (7)X-ray TV system SONIALVISION safire17 (8)X-ray TV system SONIALVISION VERSA 100 (9)X-ray TV system SONIALVISION VERSA 100R (10)X-ray TV system FLEXAVISION (11) Cassettele X-ray TV System SHIMAVISION EX Pro (12) Angiography System Trinias (13) Angiography System BRANSIST safire (14) Angiography System Partire α (15) SyncTraX Motion Tracking System for Radiation Therapy Devices (16) Diagnostic X-ray high voltage device UD150B-40 (17) Diagnostic X-ray high voltage device UD150B-40SPT (18) Diagnostic X-ray high voltage device UD150G-40 (19) Diagnostic X-ray high voltage device UD150L-40 (20) Diagnostic X-ray High Voltage Device UD150L-40E (21) Diagnostic X-ray high voltage device UD150L-40F (22) Diagnostic X-ray high voltage device XUD150L-40F |
| Manufacturer | Shimadzu Corporation |
| Models | 41E215E75004, 41F137FB9002, 417A17A49002, 081Q686001, 101A097001, 41E1D6891005, 41F1362B9001, 40AD57311001, 41E254366001, 0362R78601, 41E215D74002, 41E1D6A94002 and 15861 more |
| Date | Jun 30, 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