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Olympus Corporation of the Americas Recall 93212

Description: EVIS EXERA III Gastrointestinal Videoscope

Olympus Corporation of the Americas Recall 93212 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-0288-2024
Event ID93212
Event DescriptionEVIS EXERA III Gastrointestinal Videoscope
Product TypeDevices
DistributionNationwide Distribution.
Quantity1687 units
Recall ReasonSterilization failures when devices are sterilized per the Reprocessing Manual due to lack of drying time for the endoscope channel.
Device Classification20231115
Device Code InfoModel No. GIF-1TH190; UDI-DI: 04953170343360; All Serial Numbers.
Center Classification Date20231109
Recall Initiation Date20231002
Recalling FirmOlympus Corporation of the Americas
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