Recall Z-0754-2017— Olympus Corporation of the Americas

Name: FDA recall Z-0754-2017
Creator: U.S. Food and Drug Administration
Published: 2016-11-03

Class II · Terminated

Class II FDA medical device recall by Olympus Corporation of the Americas, initiated 2016-11-03, terminated 2019-02-06. It names one FDA 510(k) clearance: K120418. Product: HF Cable WA00014A, Endoscopic electrosurgical unit and accessories. Reason: Software malfunction that results in incorrect generation or display of error codes..

Recalling firm: Olympus Corporation of the Americas
Classification: Class II
Status: Terminated
Initiated: 2016-11-03
Terminated: 2019-02-06
Firm location: Center Valley, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K120418 — ELECTROSUGRICAL RESECTION AND VAPORIZATION ELECTRODE SERIESOlympus Winter & Ibe GmbH·cleared 2012-06-20

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

HF Cable WA00014A, Endoscopic electrosurgical unit and accessories

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.