FDAFDA · Food and drugs·Recall number Z-0224-2015
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.
Published November 26, 2014 · Recall initiated: October 24, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Visit
Recall details
- Manufacturer
- Nidek Inc
- Distributor
- US Distribution in the states of: NJ, SC, IL, MI, NY, CA, TX, OH, IN, UT, and MN.
- Lot
- 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,
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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