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

Recall Z-1207-2024 — Colonoscope, Model Number CF-HQ190L.

U.S. FDA — Device Enforcement · United States · 2024-01-11 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1207-2024
Date of alert
2024-01-11
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Olympus Corporation of the Americas
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
04953170305115
Reported risk: Specific repaired colonovideoscopes were assembled without an adhesive which protects them from certain physical conditions such as high levels of vibration, fluctuation in temperature or severe shock loads.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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