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.
This recall has been terminated (originally issued November 17, 2014).
- Company
- Nidek Inc
- Recall Initiated
- October 24, 2012
- Posted
- November 17, 2014
- Terminated
- November 17, 2014
- Recall Number
- Z-0224-2015
- Quantity
- 21affected devices
- Firm Location
- Fremont, CA
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
US Distribution in the states of: NJ, SC, IL, MI, NY, CA, TX, OH, IN, UT, and MN.
Lot / Code Info
Model MC-500 Serial numbers: 50277 50310 50330 50331 50357 50358 50383 50408 50417 50418 50425 50426 50439 50440 50445 50446 50471 50514 50311 50359 50382,
Root Cause
Device Design
Action Taken
Nidek Field Service engineers visited each affected location to upgrade software.
More recalls by Nidek Inc
NIDEK Specular Microscope, Model CEM-530 - Product Usage: The device provides noncontact, high magni...
Feb 25, 2019
AUTO REF/KERATOMETER ARK-1s
Dec 20, 2017