FDA Enforcement
Class II
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
·
Reported February 25, 2015
Enforcement
- Recall Number
- Z-1127-2015
- Event ID
- 70335
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Nidek Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Visit
- Report Date
- February 25, 2015
- Initiation Date
- March 27, 2012
- Classification Date
- February 19, 2015
- Termination Date
- February 19, 2015
- Address
- 47651 Westinghouse Dr, Fremont, CA, 94539-7474, United States
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.
Code Info
Serial numbers: 20023,20039, 20040, 20042, 20047, 20049, 20050, 20051, 20052, 20062, 20063, 20064, 20066, 20067, 20068, 20076
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