International safety notice

General name: (1) Cardiac exercise stress monitoring system (2) General-purpose electrocardiograph Sales name: (1) Marquette CASE series (2) Cardiosoft ECG

Japan / PMDA Recalls · JPN · Jun 7, 2021

Key facts

Regulator Japan / PMDA Recalls
Country JPN
Brand General name: (1) Cardiac exercise stress monitoring system (2) General-purpose electrocardiograph Sales name: (1) Marquette CASE series (2) Cardiosoft ECG
Manufacturer GE Healthcare Japan Co., Ltd.
Models 101225516, 105000255, 101233774, SHS12451294SA, 101227468, 101217200, SNP16280853SA, SPZ19130014SA, 101233249, SPZ18480003SA, 105000331, 101164693 and 53 more
Date Jun 7, 2021
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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