Nidek MC-500 Laser Photocoagulator Recalled for Power Output Failure
Nidek Inc is recalling 21 MC-500 Multicolor Laser Photocoagulators because the devices may fail to emit laser light or output lower power than programmed during retinal treatment.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk-of-harm product (medical device failure) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Nidek Inc is recalling 21 units of the MC-500 Multicolor Laser Photocoagulator, an ophthalmic device indicated for retinal photocoagulation to treat ocular fundus diseases. The recall involves devices using software version 2.20. The affected units were distributed in the United States in the states of New Jersey, South Carolina, Illinois, Michigan, New York, California, Texas, Ohio, Indiana, Utah, and Minnesota.
The recall was initiated because when the device 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. This malfunction could result in ineffective treatment for patients undergoing retinal photocoagulation.
Healthcare providers and facilities that have purchased or received these devices should stop using them and contact Nidek Inc for further instructions. The specific serial numbers affected are listed in the official recall documentation.
The recalled product
- 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.
- Manufacturer
- Nidek Inc
- Affected units
- 21
Distribution
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