HF Cable WA00014A, Endoscopic electrosurgical unit and accessories
FDA Recall Z-0754-2017 · Posted None
Recalling FirmOlympus Corporation of the Americas
Recall StatusTerminated
Product CodeFAS
Date Initiated2016-11-03
Date Terminated2019-02-06
Product Quantity494 units
Reason for Recall
Software malfunction that results in incorrect generation or display of error codes.
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.
Root Cause
Under Investigation by firm
Distribution Pattern
Distributed Nationwide
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.