Z-0754-2017Class II

HF Cable WA00014A, Endoscopic electrosurgical unit and accessories

Name: Z-0754-2017 HF Cable WA00014A, Endoscopic electrosurgical unit and accessories
Creator: Olympus Corporation of the Americas
Published: 2016-11-03
License: https://open.fda.gov/license/

OLYMPUS Corporation of the Americas / initiated 2016-11-03 / Terminated / root cause: software

FDA source

Olympus Corporation of the Americas began a recall of HF Cable WA00014A, Endoscopic electrosurgical unit and accessories on 2016-11-03. FDA classified it as Class II and gives the reason as "Software malfunction that results in incorrect generation or display of error codes". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0754-2017
Classification: Class II
Status: Terminated
Initiated: 2016-11-03
Posted: 2016-12-14
Terminated: 2019-02-06
Recalling firm: OLYMPUS Corporation of the Americas
Product: HF Cable WA00014A, Endoscopic electrosurgical unit and accessories
Product code: FAS Electrode, Electrosurgical, Active, Urological
Reason for recall: Software malfunction that results in incorrect generation or display of error codes.
Root cause tag: software
FDA root cause: Under Investigation by firm
Action: Olympus mailed on 11/03/2016 an Urgent Communication Letter to customers affected by the recall. The letter requested that consignees inspect their inventory for the affected lots and call Customer Service to obtain a Returned Material Authorization (RMA) to return the product.
Quantity in commerce: 494 units
Distribution: Distributed Nationwide
Product codes and lots: Model Number: WA00014A Lot Numbers: 158W, 159W, 15XW, 15YW, 15ZW, 161W, 162W, 163W, 164W, 165W, 166W, 167W

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0754-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0754-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-21	2016-12-14

Product code FAS

K120418Class IIElectrosugrical Resection and Vaporization Electrode SeriesOlympus Winter & Ibe GmbH / cleared 2012-06-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)