Recall Z-1127-2015— Nidek Inc
Class II · Terminated
Class II FDA medical device recall by Nidek Inc, initiated 2012-03-27, terminated 2015-02-19. It names one FDA 510(k) clearance: K110228. 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.. Reason: The spot size control of the scan delivery unit of the MC-500 Multicolor Laser Photocoagulator may turn by itself..
- Recalling firm
- Nidek Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-03-27
- Terminated
- 2015-02-19
- Firm location
- Fremont, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product 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 for recall
The spot size control of the scan delivery unit of the MC-500 Multicolor Laser Photocoagulator may turn by itself.
Data sourced from openFDA. This site is unofficial and independent of the FDA.