International safety notice

The magnetic flux density, which is a standard related to product performance and safety, was specified at 170 mT or more and 200 mT or less, but there were cases where the magnetic flux density was outside the specified range. We have identified a product with magnetic flux density and will recall the affected product.

Japan / PMDA Recalls · JPN · Jun 15, 2022

Key facts

Title The magnetic flux density, which is a standard related to product performance and safety, was specified at 170 mT or more and 200 mT or less, but there were cases where the magnetic flux density was outside the specified range. We have identified a product with magnetic flux density and will recall the affected product.
Regulator Japan / PMDA Recalls
Country JPN
Brand Common name: Home permanent magnet magnetic therapy device Brand name: Nippon Medical Pharmaceutical Magnetic Bond K
Manufacturer Japan Medical Pharmaceutical Co., Ltd.
Models 1709J7, 18027B, 20057Y, 18037C, 220301
Date Jun 15, 2022
Regulator page info.pmda.go.jp

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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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