International safety notice

Common names: (1) Stationary digital general-purpose X-ray fluoroscopy diagnostic equipment, (2)-(3) Stationary digital circulatory system X-ray fluoroscopy diagnostic equipment Sales name: (1) Entegris Vascular Series (2) Entegris Allura Flat Detector (3) Angiography X-ray diagnostic device Azurion

Japan / PMDA Recalls · JPN · Dec 21, 2023

Key facts

Regulator Japan / PMDA Recalls
Country JPN
Brand Common names: (1) Stationary digital general-purpose X-ray fluoroscopy diagnostic equipment, (2)-(3) Stationary digital circulatory system X-ray fluoroscopy diagnostic equipment Sales name: (1) Entegris Vascular Series (2) Entegris Allura Flat Detector (3) Angiography X-ray diagnostic device Azurion
Manufacturer Philips Japan Co., Ltd.
Models 722228, 722035, 722012, 14753766, 722078, 703363, 17944815, 722028, 722003, 722079, 722043, 722015 and 10 more
Date Dec 21, 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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