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Class 2 Device Recall HF Cable WA00014A |
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Date Initiated by Firm |
November 03, 2016 |
Create Date |
December 14, 2016 |
Recall Status1 |
Terminated 3 on February 06, 2019 |
Recall Number |
Z-0754-2017 |
Recall Event ID |
75601 |
510(K)Number |
K120418
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Product Classification |
Electrode, electrosurgical, active, urological - Product Code FAS
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Product |
HF Cable WA00014A, Endoscopic electrosurgical unit and accessories |
Code Information |
Model Number: WA00014A Lot Numbers: 158W, 159W, 15XW, 15YW, 15ZW, 161W, 162W, 163W, 164W, 165W, 166W, 167W |
Recalling Firm/ Manufacturer |
Olympus Corporation of the Americas 3500 Corporate Pkwy PO Box 610 Center Valley PA 18034-0610
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For Additional Information Contact |
Laura Storms 484-8965688
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Manufacturer Reason for Recall |
Software malfunction that results in incorrect generation or display of error codes.
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FDA Determined Cause 2 |
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 |
Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database |
510(K)s with Product Code = FAS and Original Applicant = OLYMPUS WINTER & IBE GMBH
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