FDA Enforcement
Class II
Terminated
HF Cable WA00014A, Endoscopic electrosurgical unit and accessories
Recall: Z-0754-2017
·
Reported December 21, 2016
Enforcement
- Recall Number
- Z-0754-2017
- Event ID
- 75601
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Olympus Corporation of the Americas
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- December 21, 2016
- Initiation Date
- November 3, 2016
- Classification Date
- December 14, 2016
- Termination Date
- February 6, 2019
- Address
- 3500 Corporate Pkwy, PO Box 610, Center Valley, PA, 18034-0610, United States
Description
HF Cable WA00014A, Endoscopic electrosurgical unit and accessories
Reason
Software malfunction that results in incorrect generation or display of error codes.
Code Info
Model Number: WA00014A Lot Numbers: 158W, 159W, 15XW, 15YW, 15ZW, 161W, 162W, 163W, 164W, 165W, 166W, 167W
Distribution
Distributed Nationwide
Quantity
494 units