International safety notice

There is a risk of the handle being damaged. There is a possibility that the temperature of the plastic in the handle part of the product from the foreign manufacturer was not high enough when forming it. This is because we received information that the strength may be insufficient.

Japan / PMDA Recalls · JPN · Feb 28, 2023

Key facts

Title There is a risk of the handle being damaged. There is a possibility that the temperature of the plastic in the handle part of the product from the foreign manufacturer was not high enough when forming it. This is because we received information that the strength may be insufficient.
Regulator Japan / PMDA Recalls
Country JPN
Brand Common name: Home electric massager Sales name: MYTREX Revive RBV22
Manufacturer Sotsu Medical Co., Ltd.
Models BL002SQB
Date Feb 28, 2023
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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