International safety notice

Some products manufactured by overseas manufacturers during a certain period may not be able to connect wirelessly (paired) with Apple devices. As it was discovered that the connection was interrupted when the connection was disconnected, the company announced that it would implement a voluntary recall and replacement service. I have been contacted. Therefore, our company has decided to carry out a voluntary recall of the affected products.

Japan / PMDA Recalls · JPN · Jun 1, 2022

Key facts

Title Some products manufactured by overseas manufacturers during a certain period may not be able to connect wirelessly (paired) with Apple devices. As it was discovered that the connection was interrupted when the connection was disconnected, the company announced that it would implement a voluntary recall and replacement service. I have been contacted. Therefore, our company has decided to carry out a voluntary recall of the affected products.
Regulator Japan / PMDA Recalls
Country JPN
Brand Common name: Artificial inner ear Sales name: Nucleus 7 Sound Processor
Manufacturer Cochlear Japan Co., Ltd.
Models 1010145019403, 1010145010127, 1010145070374, 1010145019274, 1010145074839, 1010145074716, 1010145072392, 1010145019359, 1010145094981, 1010145075065, 1010145019397, 1010145072347 and 2 more
Date Jun 1, 2022
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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