International safety notice

In some products of the "Extension Tunneler Kit" that comes with this product, both sides of the dual carrier that is a component It was confirmed that the carrier port was processed only on one side. We will carry out a voluntary recall for specific lot numbers.

Japan / PMDA Recalls · JPN · Mar 20, 2023

Key facts

Title In some products of the "Extension Tunneler Kit" that comes with this product, both sides of the dual carrier that is a component It was confirmed that the carrier port was processed only on one side. We will carry out a voluntary recall for specific lot numbers.
Regulator Japan / PMDA Recalls
Country JPN
Brand Common name: Brain electrical stimulation device for shaking Brand name: Medtronic SenSight
Manufacturer Japan Medtronic Co., Ltd.
Models HG59SJ4, HG5A9H3, HG5A9VY, B31030, HG59ABH, HG59RY0, HG5BQAW, HG5A9NB, HG59SNC, HG5BQ5Y, HG5BQLR
Date Mar 20, 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

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Source: National medical device regulators (as listed), compiled by Orca1

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