International safety notice

The manufacturing facility has reported that the product was manufactured using a manufacturing method that may not comply with the maximum magnetic flux density specified by the certification standards. As a result, we will voluntarily recall the products in the affected lots.

Japan / PMDA Recalls · JPN · Apr 27, 2023

Key facts

Title The manufacturing facility has reported that the product was manufactured using a manufacturing method that may not comply with the maximum magnetic flux density specified by the certification standards. As a result, we will voluntarily recall the products in the affected lots.
Regulator Japan / PMDA Recalls
Country JPN
Brand Common name: Home permanent magnet magnetic therapy device Brand name: (1) Nippon Medical Pharmaceutical Magnetic Bond K (2) Magnetic necklace TM056 (3) Magnetic loop TM026 (4) Magnetic necklace TM086 (5) Magnetic loop TM025 (6) Magnetic necklace TM004 (7) Magnetic loop TM106L
Manufacturer Japan Medical Pharmaceutical Co., Ltd.
Models AP2,AR5,AS4, 2207J28,2207J30, AR5,AS4
Date Apr 27, 2023
Regulator page info.pmda.go.jp

At a glance

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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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