FDA Recall
Terminated
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: Z-1127-2015
·
Initiated March 27, 2012
Recall
- Recall Number
- Z-1127-2015
- Event Number
- 70335
- Firm
- Nidek Inc
- FEI Number
- 2936921
- Product Code
- HQF
- Status
- Terminated
- Root Cause
- Component design/selection
- Initiated
- March 27, 2012
- Posted
- February 19, 2015
- Terminated
- February 19, 2015
- Address
- 47651 Westinghouse Dr, Fremont, CA, 94539-7474
Description
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.
Reason
The spot size control of the scan delivery unit of the MC-500 Multicolor Laser Photocoagulator may turn by itself.
Action
Nidek Japan issues a Engineering Change Order and Nidek reps visited affected sites to perform correction.
Distribution
Nationwide Distribution- including the states of CA, MI, NY, IL, NH, KS, NY, UT, IA, WI, TX, and FL.
Quantity
16 units in commerce