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.
This recall has been terminated (originally issued February 19, 2015).
- Company
- Nidek Inc
- Recall Initiated
- March 27, 2012
- Posted
- February 19, 2015
- Terminated
- February 19, 2015
- Recall Number
- Z-1127-2015
- Quantity
- 16 units in commerce
- Firm Location
- Fremont, CA
- Official Source
- View on FDA website ↗
Reason for Recall
The spot size control of the scan delivery unit of the MC-500 Multicolor Laser Photocoagulator may turn by itself.
Distribution
Nationwide Distribution- including the states of CA, MI, NY, IL, NH, KS, NY, UT, IA, WI, TX, and FL.
Lot / Code Info
Serial numbers: 20023,20039, 20040, 20042, 20047, 20049, 20050, 20051, 20052, 20062, 20063, 20064, 20066, 20067, 20068, 20076
Root Cause
Component design/selection
Action Taken
Nidek Japan issues a Engineering Change Order and Nidek reps visited affected sites to perform correction.
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