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Recall Observatory FDA recall evidence

Device product

HF Cable WA00014A, Endoscopic electrosurgical unit and accessories

Z-0754-2017

November 03, 2016

Class II

Product summary

Firm
Olympus Corporation of the Americas
Event
Event 75601
Status
Terminated
Classification
Class II
Quantity
494 units
Official record key
device-enforcement:Z-0754-2017

Official wording

Reason: Software malfunction that results in incorrect generation or display of error codes.

Code information: Model Number: WA00014A Lot Numbers: 158W, 159W, 15XW, 15YW, 15ZW, 161W, 162W, 163W, 164W, 165W, 166W, 167W

Distribution pattern: Distributed Nationwide

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    Software malfunction that results in incorrect