International safety notice

After receiving reports of burns occurring in multiple cases of children using this product overseas, the overseas manufacturer conducted an investigation. As a result, we decided to voluntarily recall the product because we could not deny the possibility that burns could occur if certain conditions overlap. I said. vinegar.

Japan / PMDA Recalls · JPN · May 22, 2024

Key facts

Title After receiving reports of burns occurring in multiple cases of children using this product overseas, the overseas manufacturer conducted an investigation. As a result, we decided to voluntarily recall the product because we could not deny the possibility that burns could occur if certain conditions overlap. I said. vinegar.
Regulator Japan / PMDA Recalls
Country JPN
Brand Common name: treatment return electrode Sales name: Megasoft
Manufacturer Johnson & Johnson Co., Ltd.
Models GS23022703, GS22025605, GS24001904, GS22025602, GS24001906, GS23006502, S22033704, GS23022701, GS22035701, GS22033701, GS22033703, GS24001903 and 13 more
Date May 22, 2024
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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