FDA Medical Device Recalls (openFDA)
Nidek Inc: MC-500 Multicolor Laser Photocoagulator; Indicated for use in retinal photocoagulation for treatment of ocular fundus diseases like diabetic retinopathy, age-related macular degeneration, retinopathy of prematurity and retinal detachment.
- Recall number
- Z-1127-2015
- Recalling firm
- Nidek Inc
- Product
- MC-500 Multicolor Laser Photocoagulator; Indicated for use in retinal photocoagulation for treatment of ocular fundus diseases like diabetic retinopathy, age-related macular degeneration, retinopathy of prematurity and retinal detachment.
- Status
- Terminated
- Initiated
- 2012-03-27
- Posted
- 2015-02-19
- Terminated
- 2015-02-19
- Reason
- The spot size control of the scan delivery unit of the MC-500 Multicolor Laser Photocoagulator may turn by itself.
- Root cause
- Component design/selection
- Action
- Nidek Japan issues a Engineering Change Order and Nidek reps visited affected sites to perform correction.
- Quantity
- 16 units in commerce
- Distribution
- Nationwide Distribution- including the states of CA, MI, NY, IL, NH, KS, NY, UT, IA, WI, TX, and FL.
- Lot, serial or model codes
- Serial numbers: 20023,20039, 20040, 20042, 20047, 20049, 20050, 20051, 20052, 20062, 20063, 20064, 20066, 20067, 20068, 20076
- 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