Z-0224-2015 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- November 26, 2014
- Initiation Date
- October 24, 2012
- Termination Date
- November 17, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 21affected devices
Product Description
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.
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 Pattern
US Distribution in the states of: NJ, SC, IL, MI, NY, CA, TX, OH, IN, UT, and MN.
Code Information
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,