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Aizu Olympus Co., Ltd. Recall 93222

Description: Gastroscope-endoscopic ultrasound (EUS) guided fine needle aspiration (FNA) and for endoscopic surgery within the upper digestive tract. Models: GF-UC140P-AL5 GF-UCT180 GF-UE160-AL5

Aizu Olympus Co., Ltd. Recall 93222 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0333-2024
Event ID93222
Event DescriptionGastroscope-endoscopic ultrasound (EUS) guided fine needle aspiration (FNA) and for endoscopic surgery within the upper digestive tract. Models: GF-UC140P-AL5 GF-UCT180 GF-UE160-AL5
Product TypeDevices
DistributionWorldwide - US Nationwide distribution.
Quantity680 units
Recall ReasonChannel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of infection
Device Classification20231129
Device Code InfoUDI-DI: GF-UC140P-AL5 04953170356322 GF-UCT180 04953170356339 GF-UE160-AL5 04953170356261
Center Classification Date20231117
Recall Initiation Date20230925
Recalling FirmAizu Olympus Co., Ltd.
Initial Notification Letter
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