Recall Z-0222-2015 ยท HQF Laser, Ophthalmic
Nidek Inc
MC-500 Multicolor Laser Photocoagulator using software version 2.20. Opthalmic device used for retinal photocoagulation for treatment of ocular fundus diseases.
| Date | Nov 17, 2014 (initiated May 24, 2013) |
| Status | Terminated |
| Reason | Retrospective review found that a Engineering Change Order initiated in May 2013 for a memory function problem was not reported as required. |
| Root cause | Software design |
| Action | Nidek Engineers visited all affected sites to install new software version. For questions regarding this recall call 510-353-7785. |
| Quantity | 5 |
| Distribution | US Distribution in the states of: CA, NE, and NY. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K110228 | NIDEK MULTICOLOR LASER PHOTOCOAGULATOR Nidek Incorporated, Feb 23, 2011 |