International safety notice

Common name: Stationary digital breast X-ray diagnostic device Brand name: Breast X-ray diagnostic device Senographe Pristina

Japan / PMDA Recalls · JPN · Jan 26, 2024

Key facts

Regulator Japan / PMDA Recalls
Country JPN
Brand Common name: Stationary digital breast X-ray diagnostic device Brand name: Breast X-ray diagnostic device Senographe Pristina
Manufacturer GE Healthcare Japan Co., Ltd.
Models 857389BU1, 854957BU8, 854775BU4, 855324BU0, 858570BU5, 859914BU4, 859161BU2
Date Jan 26, 2024
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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