International safety notice

Some serial numbers of this product incorporate parts that deviate from the specifications, so when used in combination with an endoscope, We recently discovered that this product may not start up properly and endoscopic images may not be displayed.

Japan / PMDA Recalls · JPN · Oct 17, 2023

Key facts

Title Some serial numbers of this product incorporate parts that deviate from the specifications, so when used in combination with an endoscope, We recently discovered that this product may not start up properly and endoscopic images may not be displayed.
Regulator Japan / PMDA Recalls
Country JPN
Brand Common name: Endoscopic video image processor Sales name: (1)EVIS EXERA III Video System Center OLYMPUS CV-190 PLUS (2)EVIS LUCERA ELITE Video System Center OLYMPUS CV-290
Manufacturer Olympus Medical Systems Co., Ltd.
Models 7321391, 7041648,7210187,7210253,7389686,7389692
Date Oct 17, 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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