FDA Medical Device Recalls (openFDA)
Alcon Research, Ltd.: CENTURION Vision System
- Recall number
- Z-2081-2016
- Recalling firm
- Alcon Research, Ltd.
- Product
- CENTURION Vision System
- Status
- Terminated
- Initiated
- 2016-05-24
- Posted
- 2016-06-28
- Terminated
- 2017-04-13
- Reason
- The grounding pin within the Power Entry Switch on certain systems was susceptible to detachment when the AC power cable is removed.
- Root cause
- Nonconforming Material/Component
- Action
- Alcon has already notified the affected customer verbally on May 24, 2016, and via written correspondence on June 1, 2016. The device was corrected on May 26, 2016, and the Power Entry Switch that was removed from the customers CENTURION Vision System did not exhibit a grounding pin susceptible to detachment. For further questions, please call (817) 293-0450.
- Quantity
- 1 unit
- Distribution
- US Distribution to Illinois
- Lot, serial or model codes
- Serial Number 1601444801X
- 510(k) numbers
- ["K121555"]
- PMA numbers
- not on file
- Product code
- HQC
- Firm FEI
- 1610287
- Firm city
- Fort Worth
- Firm state
- TX
- 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