International safety notice

When checking inventory, cracks in the casing and damage to the battery cover were found, so we conducted a voluntary recall of the lot. I will do it.

Japan / PMDA Recalls · JPN · Jun 28, 2024

Key facts

Title When checking inventory, cracks in the casing and damage to the battery cover were found, so we conducted a voluntary recall of the lot. I will do it.
Regulator Japan / PMDA Recalls
Country JPN
Brand Common name: Long-term electrocardiographic data recorder Sales name: Lotus Heart
Manufacturer Hamada Co., Ltd.
Models 2312100001, 2312100200
Date Jun 28, 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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