21
Dec
2016

Olympus HF Cable WA00014A Cl II

0

Company: Olympus Corporation of the Americas
Date of Enforcement Report 12/21/2016
Class lI:

PRODUCT

HF Cable WA00014A, Endoscopic electrosurgical unit and accessories
Recall Number Z-0754-2017

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

RECALLING FIRM/MANUFACTURER
Olympus Corporation of the Americas, Center Valley, PA on 11/3/2016. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
494 units

DISTRIBUTION
Nationwide

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About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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