MC-500 Multicolor Laser Photocoagulator using software version 2.20. Opthalmic device used for retinal photocoagulation
FDA device recall Z-0222-2015 · posted 2014-11-17 · Terminated
Recall details
- Recalling firm
- Nidek Inc
- Reason for recall
- Retrospective review found that a Engineering Change Order initiated in May 2013 for a memory function problem was not reported as required.
- Action taken
- Nidek Engineers visited all affected sites to install new software version. For questions regarding this recall call 510-353-7785.
- Root cause
- Software design
- Status
- Terminated
- Product code
- HQF
- Quantity affected
- 5
- Distribution
- US Distribution in the states of: CA, NE, and NY.
- Date initiated
- 2013-05-24
- Date posted
- 2014-11-17
- Date terminated
- 2014-11-17
- 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 |