FDA Medical Device Recalls (openFDA)
Olympus Corporation of the Americas: HF Cable WA00014A, Endoscopic electrosurgical unit and accessories
- Recall number
- Z-0754-2017
- Recalling firm
- Olympus Corporation of the Americas
- Product
- HF Cable WA00014A, Endoscopic electrosurgical unit and accessories
- Status
- Terminated
- Initiated
- 2016-11-03
- Posted
- not on file
- Terminated
- 2019-02-06
- Reason
- Software malfunction that results in incorrect generation or display of error codes.
- 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
- 494 units
- Distribution
- Distributed Nationwide
- Lot, serial or model codes
- Model Number: WA00014A Lot Numbers: 158W, 159W, 15XW, 15YW, 15ZW, 161W, 162W, 163W, 164W, 165W, 166W, 167W
- 510(k) numbers
- ["K120418"]
- PMA numbers
- not on file
- Product code
- FAS
- Firm FEI
- 2429304
- Firm city
- Center Valley
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28