Recall Z-1127-2015
Nidek Inc · initiated March 27, 2012
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: Serial numbers: 20023,20039, 20040, 20042, 20047, 20049, 20050, 20051, 20052, 20062, 20063, 20064, 20066, 20067, 20068, 20076
Reason for recall
The spot size control of the scan delivery unit of the MC-500 Multicolor Laser Photocoagulator may turn by itself.
FDA-determined cause: Component design/selection
Action taken
Nidek Japan issues a Engineering Change Order and Nidek reps visited affected sites to perform correction.
Details
- Recall number
- Z-1127-2015
- Initiated
- March 27, 2012
- Posted by FDA
- February 19, 2015
- Terminated
- February 19, 2015
- Product code
- HQF – Laser, Ophthalmic
- 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.
- Recalling firm
- Nidek Inc, Fremont, CA