International safety notice

It has been discovered that the overseas manufacturing facility for this product has been relocated, and products manufactured at a manufacturing facility that differs from the manufacturing and sales notification are being distributed. Ta. We have decided to carry out a voluntary recall of the products produced at the relocated manufacturing facility.

Japan / PMDA Recalls · JPN · May 27, 2022

Key facts

Title It has been discovered that the overseas manufacturing facility for this product has been relocated, and products manufactured at a manufacturing facility that differs from the manufacturing and sales notification are being distributed. Ta. We have decided to carry out a voluntary recall of the products produced at the relocated manufacturing facility.
Regulator Japan / PMDA Recalls
Country JPN
Brand Common name: Portable surgical microscope Brand name: Vein visualization device AccuVein AV500
Manufacturer ICST Co., Ltd.
Models AV20490172, AV20490269, AV20340142, AV21460232, AV21280122, AV22010229, AV20470130, AV20490217, AV21280112, AV20470129, AV20470118, AV20490161 and 135 more
Date May 27, 2022
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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