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Olympus Corporation of the Americas Recall 89921

Description: Ultrasonic Gastrovideoscope, GF-UC140P-AL5. Intended for endoscopic real-time ultrasound imaging.

Olympus Corporation of the Americas Recall 89921 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-1034-2022
Event ID89921
Event DescriptionUltrasonic Gastrovideoscope, GF-UC140P-AL5. Intended for endoscopic real-time ultrasound imaging.
Product TypeDevices
DistributionNationwide
Quantity731 units
Recall ReasonGF-UC140P-AL5 is no longer a compatible endoscope for reprocessing in the OER-Pro and presents an infection control risk to patients
Device Classification20220511
Device Code InfoAll serial numbers. GTIN: 04953170356322
Center Classification Date20220505
Recall Initiation Date20220318
Recalling FirmOlympus Corporation of the Americas
Initial Notification Letter
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