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Recall Observatory FDA recall evidence

Device product

FLEXIBLE NEURO-FIBERSCOPE, 3.7MM X 34CM, Model # 11282BN1

Z-2425-2019

February 20, 2019

Class II

Product summary

Firm
Karl Storz Endoscopy
Event
Event 83459
Status
Terminated
Classification
Class II
Quantity
22 scopes
Official record key
device-enforcement:Z-2425-2019

Official wording

Reason: The action is being initiated due to Flexible Neuroscopes manufactured with the incorrect channel port.

Code information: SERIAL NUMBER: 2161516, 2204079, 2172240, 2198276, 2062041, 2178784, 2198341, 2220959, 2210200, 2183837, 2188370, 2247464, 2248783, 2194154, 2244117, 2039298

Distribution pattern: US: FL, MO, MA, AL,CA, OH, PA,NH, OR, WA, MI, NC, CA, VA

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The action is being initiated due to Flexible Neuroscopes manufactured with the incorrect channel port.