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Recall Observatory FDA recall evidence

Device product

Olympus, Model No. XCF-Q160ALE, flexible scope, large diameter, video colonoscope

Z-0910-2016

January 20, 2016

Class II

Product summary

Firm
Integrated Medical Systems Inc
Event
Event 73088
Status
Terminated
Classification
Class II
Quantity
1 instrument
Official record key
device-enforcement:Z-0910-2016

Official wording

Reason: 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.

Code information: Serial Number 240T024

Distribution pattern: Distributed US (nationwide) and in Australia.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.