International safety notice

In the target product, the model (version) of the monitor, which is the main component, is older than the model listed in the approval letter. We have decided to carry out a voluntary recall.

Japan / PMDA Recalls · JPN · Dec 7, 2023

Key facts

Title In the target product, the model (version) of the monitor, which is the main component, is older than the model listed in the approval letter. We have decided to carry out a voluntary recall.
Regulator Japan / PMDA Recalls
Country JPN
Brand Common name: Navigation device for central venous catheter placement Sales name: Sherlock 3CG Plus
Manufacturer Medicon Co., Ltd.
Models ASEVAF022, 9770371, ASEVAF021
Date Dec 7, 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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