Recall Z-0224-2015 ยท HQF Laser, Ophthalmic
Nidek Inc
Nidek MC-500 Multicolor Laser Photocoagulator using software version 2.20. Opthalmic Device. The Nidek Multicolor Laser photocoagulator Model MC-500 is indicated for use in retinal photocoagulation for treatment of ocular fundus diseases.
| Date | Nov 17, 2014 (initiated Oct 24, 2012) |
| Status | Terminated |
| Reason | When the MC-500 is turned on and coagulation is performed without changing the laser color, the delivery unit occasionally fails to emit the laser, or the power output is lower than the set program. |
| Root cause | Device Design |
| Action | Nidek Field Service engineers visited each affected location to upgrade software. |
| Quantity | 21affected devices |
| Distribution | US Distribution in the states of: NJ, SC, IL, MI, NY, CA, TX, OH, IN, UT, and MN. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K110228 | NIDEK MULTICOLOR LASER PHOTOCOAGULATOR Nidek Incorporated, Feb 23, 2011 |