International safety notice

General name: X-ray fluoroscopy diagnostic device for stand-alone Fukuro type circulator Brand name: (1) X-ray cardiovascular diagnostic system Alphenix INFX-8000C (2) X-ray circulator diagnosis system Alphanix INFX-8000V

Japan / PMDA Recalls · JPN · Jun 12, 2024

Key facts

Regulator Japan / PMDA Recalls
Country JPN
Brand General name: X-ray fluoroscopy diagnostic device for stand-alone Fukuro type circulator Brand name: (1) X-ray cardiovascular diagnostic system Alphenix INFX-8000C (2) X-ray circulator diagnosis system Alphanix INFX-8000V
Manufacturer Canon Medical Systems Inc.
Models INFX-8000C, H5E23Z2013, TKC2412027, TKC2442030, TBA23Z2007, TBA2412008, T7C2442019, T7C2442020, TKC2422028, TMA2432005, H9E2412018, T7C2422018 and 29 more
Date Jun 12, 2024
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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