International safety notice

Common name: Stationary digital cardiovascular X-ray fluoroscopic diagnostic equipment Brand name: (1) X-ray cardiovascular diagnostic system Alphenix INFX-8000C (2) X-ray cardiovascular diagnostic system Alphenix INFX-8000V

Japan / PMDA Recalls · JPN · Nov 2, 2021

Key facts

Regulator Japan / PMDA Recalls
Country JPN
Brand Common name: Stationary digital cardiovascular X-ray fluoroscopic diagnostic equipment Brand name: (1) X-ray cardiovascular diagnostic system Alphenix INFX-8000C (2) X-ray cardiovascular diagnostic system Alphenix INFX-8000V
Manufacturer Canon Medical Systems Inc.
Models T7B2172003, H7C2112021, N7B15X2022, HKC20Z2014, T7B2172004, H7C20Z2020, J4E12X2045, JCD1262061, HKC2122015, TKA2142001, JDE12Y2004, TKB2182003 and 17 more
Date Nov 2, 2021
Regulator page info.pmda.go.jp

At a glance

  • No Recall
  • No Field safety notice

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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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