Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0419-2024 — PCF-H190L, EVIS EXERA III COLONOVIDEOSCOPE

U.S. FDA — Device Enforcement · Japan · 2023-10-16 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0419-2024
Date of alert
2023-10-16
Country / jurisdiction
Japan
Risk level
Class II
Risk type
recall
Brand
Aizu Olympus Co., Ltd.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
04953170305191
Reported risk: Specific devices may have an improperly repaired light guide connector due to missing adhesive to secure the suction channel mouthpiece to the scope connector. Issue may result in loss of image, decreased suction, or impact the ability to effectively reprocess the device. This in turn may lead to unanticipated delay to treatment, or patient exposure to contaminated material and subsequent infection.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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