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

Recall Z-0903-2016 — Olympus, Model No. CF-140L, flexible scope, large diameter, video colonoscope

U.S. FDA — Device Enforcement · United States · 2016-01-20 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0903-2016
Date of alert
2016-01-20
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Integrated Medical Systems Inc
Product category
device
Product type
Devices
Reported risk: If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end of the endoscope can become detached and angulation may not operate as intended.
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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