FDA Medical Device Recalls (openFDA)
Nidek Inc: MC-500 Multicolor Laser Photocoagulator using software version 2.20. Opthalmic device used for retinal photocoagulation for treatment of ocular fundus diseases.
- Recall number
- Z-0222-2015
- Recalling firm
- Nidek Inc
- Product
- MC-500 Multicolor Laser Photocoagulator using software version 2.20. Opthalmic device used for retinal photocoagulation for treatment of ocular fundus diseases.
- Status
- Terminated
- Initiated
- 2013-05-24
- Posted
- 2014-11-17
- Terminated
- 2014-11-17
- Reason
- Retrospective review found that a Engineering Change Order initiated in May 2013 for a memory function problem was not reported as required.
- Root cause
- Software design
- Action
- Nidek Engineers visited all affected sites to install new software version. For questions regarding this recall call 510-353-7785.
- Quantity
- 5
- Distribution
- US Distribution in the states of: CA, NE, and NY.
- Lot, serial or model codes
- MC-500; Serial numbers: 50011, 50382, 50425, 50558, 50609
- 510(k) numbers
- ["K110228"]
- PMA numbers
- not on file
- Product code
- HQF
- Firm FEI
- 2936921
- Firm city
- Fremont
- Firm state
- CA
- 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