Recall Z-0224-2015
Nidek Inc · initiated October 24, 2012
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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.
Codes / lots: 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,
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.
FDA-determined cause: Device Design
Action taken
Nidek Field Service engineers visited each affected location to upgrade software.
Details
- Recall number
- Z-0224-2015
- Initiated
- October 24, 2012
- Posted by FDA
- November 17, 2014
- Terminated
- November 17, 2014
- Product code
- HQF – Laser, Ophthalmic
- Quantity
- 21affected devices
- Distribution
- US Distribution in the states of: NJ, SC, IL, MI, NY, CA, TX, OH, IN, UT, and MN.
- Recalling firm
- Nidek Inc, Fremont, CA