MC-500 Multicolor Laser Photocoagulator; Indicated for use in retinal photocoagulation for treatment of ocular fundus di
FDA device recall Z-1127-2015 · posted 2015-02-19 · Terminated
Recall details
- Recalling firm
- Nidek Inc
- Reason for recall
- The spot size control of the scan delivery unit of the MC-500 Multicolor Laser Photocoagulator may turn by itself.
- Action taken
- Nidek Japan issues a Engineering Change Order and Nidek reps visited affected sites to perform correction.
- Root cause
- Component design/selection
- Status
- Terminated
- Product code
- HQF
- Quantity affected
- 16 units in commerce
- Distribution
- Nationwide Distribution- including the states of CA, MI, NY, IL, NH, KS, NY, UT, IA, WI, TX, and FL.
- Date initiated
- 2012-03-27
- Date posted
- 2015-02-19
- Date terminated
- 2015-02-19
- Location
- Fremont, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| NIDEK MULTICOLOR LASER PHOTOCOAGULATOR (K110228) | Nidek Incorporated | 2011-02-23 |