Device 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.
Z-1127-2015
Product summary
- Firm
- Nidek Inc
- Event
- Event 70335
- Status
- Terminated
- Classification
- Class II
- Quantity
- 16 units in commerce
- Official record key
device-enforcement:Z-1127-2015
Official wording
Reason: The spot size control of the scan delivery unit of the MC-500 Multicolor Laser Photocoagulator may turn by itself.
Code information: Serial numbers: 20023,20039, 20040, 20042, 20047, 20049, 20050, 20051, 20052, 20062, 20063, 20064, 20066, 20067, 20068, 20076
Distribution pattern: Nationwide Distribution- including the states of CA, MI, NY, IL, NH, KS, NY, UT, IA, WI, TX, and FL.
Derived failure modes
-
Unknown
The spot size control of the scan delivery unit of the MC-500 Multicolor Laser Photocoagulator may turn by itself.