Recalls / —
—#150883
Product
HF Cable WA00014A, Endoscopic electrosurgical unit and accessories
- FDA product code
- FAS — Electrode, Electrosurgical, Active, Urological
- Device class
- Class 2
- Medical specialty
- Gastroenterology, Urology
- 510(k) numbers
- K120418
- Affected lot / code info
- Model Number: WA00014A Lot Numbers: 158W, 159W, 15XW, 15YW, 15ZW, 161W, 162W, 163W, 164W, 165W, 166W, 167W
Why it was recalled
Software malfunction that results in incorrect generation or display of error codes.
Root cause (FDA determination)
Under Investigation by firm
Action the firm took
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.
Recalling firm
- Firm
- Olympus Corporation of the Americas
- Address
- 3500 Corporate Pkwy PO Box 610, Center Valley, Pennsylvania 18034-0610
Distribution
- Distribution pattern
- Distributed Nationwide
Timeline
- Recall initiated
- 2016-11-03
- Terminated
- 2019-02-06
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #150883. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.