Nidek MC-500 Laser Photocoagulator Recalled for Spot Size Control Defect
Nidek Inc is recalling 16 MC-500 Multicolor Laser Photocoagulators because the spot size control may turn by itself, posing a risk of unintended laser delivery.
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 (laser device) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Nidek Inc is recalling 16 units of the MC-500 Multicolor Laser Photocoagulator. This medical device is indicated for use in retinal photocoagulation to treat ocular fundus diseases, including diabetic retinopathy, age-related macular degeneration, retinopathy of prematurity, and retinal detachment.
The recall is due to a defect in the scan delivery unit where the spot size control may turn by itself. This malfunction could result in unintended laser delivery during a procedure. The affected units were distributed nationwide, including in California, Michigan, New York, Illinois, New Hampshire, Kansas, Utah, Iowa, Wisconsin, Texas, and Florida.
The specific serial numbers affected are 20023, 20039, 20040, 20042, 20047, 20049, 20050, 20051, 20052, 20062, 20063, 20064, 20066, 20067, 20068, and 20076. Healthcare facilities and users should stop using these devices and contact Nidek Inc for further instructions on the recall.
The recalled product
- Product
- MC-500 Multicolor Laser Photocoagulator; Indicated for use in retinal photocoagulation for treatment of ocular fundus diseases like diabetic retinopathy, age-related macular degeneration, retinopathy of prematurity and retinal detachment.
- Manufacturer
- Nidek Inc
- Affected units
- 16
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (16)
- Serial numbers: 20023
- 20039
- 20040
- 20042
- 20047
- 20049
- 20050
- 20051
- 20052
- 20062
- 20063
- 20064
- 20066
- 20067
- 20068
- 20076
Distribution
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