International safety notice

Common names: (1) - (5) Stationary digital general-purpose X-ray diagnostic equipment, (6), (7) Ceiling-mounted X-ray tube support Sales name: (1) Digital general X-ray imaging system RADspeed safire (2) Diagnostic X-ray device RADspeed Pro (3) Digital general X-ray imaging system DR-XD100 (4) Diagnostic X-ray device DR-XD101 (5) Diagnostic X-ray equipment FUJIFILM DR BENEO-Fx (6) Atrium walking X-ray tube hanger CH-200 (7) Atrium walking X-ray tube hanger CH-200M

Japan / PMDA Recalls · JPN · Apr 12, 2023

Key facts

Regulator Japan / PMDA Recalls
Country JPN
Brand Common names: (1) - (5) Stationary digital general-purpose X-ray diagnostic equipment, (6), (7) Ceiling-mounted X-ray tube support Sales name: (1) Digital general X-ray imaging system RADspeed safire (2) Diagnostic X-ray device RADspeed Pro (3) Digital general X-ray imaging system DR-XD100 (4) Diagnostic X-ray device DR-XD101 (5) Diagnostic X-ray equipment FUJIFILM DR BENEO-Fx (6) Atrium walking X-ray tube hanger CH-200 (7) Atrium walking X-ray tube hanger CH-200M
Manufacturer Shimadzu Corporation
Models 0362M41509, 0162M44810, 416FD3A82001, 0162M42312, 101A124801, 101B872601, 0562M41404, 0162M43913, 0162M41802, 0562M44206, 3ZC5C103C019, 3ZC5C2071003 and 6563 more
Date Apr 12, 2023
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

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