International safety notice

General name: Whole-body X-ray CT diagnostic device Sales name: (1) Multi-slice CT scanner LightSpeed (2) Whole-body X-ray CT diagnostic device BrightSpeed (3) Revolution Maxima

Japan / PMDA Recalls · JPN · Nov 29, 2024

Key facts

Regulator Japan / PMDA Recalls
Country JPN
Brand General name: Whole-body X-ray CT diagnostic device Sales name: (1) Multi-slice CT scanner LightSpeed (2) Whole-body X-ray CT diagnostic device BrightSpeed (3) Revolution Maxima
Manufacturer GE Healthcare Japan Co., Ltd.
Models CT00528, CT00599, CT00624, BK1115, CT00622
Date Nov 29, 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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