Nidek MC-500 Laser Photocoagulator Recalled for Missing Aperture Label
Nidek Inc. is recalling 29 MC-500 Multicolor Laser Photocoagulators because the laser aperture label was not affixed to the devices prior to shipment.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. The missing label is a documentation and safety marking issue rather than a functional defect causing direct injury, fitting the Moderate severity criteria for labeling errors.
Plain-English summary
Nidek Inc. is recalling 29 units of the MC-500 Multicolor Laser Photocoagulator, a medical device used for ophthalmic and retinal procedures. The recall was initiated because the laser aperture label was not affixed to the devices prior to shipment in the United States.
The affected devices were distributed nationwide, including in Illinois, Nebraska, New York, New Hampshire, Colorado, Michigan, Texas, California, Pennsylvania, Florida, Kansas, Utah, Minnesota, Wisconsin, Missouri, and Oregon. The recall involves 29 units, of which 26 have already been re-labeled. The specific part number is 173530U20, and the affected serial numbers are listed in the official recall documentation.
Healthcare providers and consumers should check their inventory for these specific serial numbers. If a device is found without the required laser aperture label, it should be removed from service and the manufacturer contacted for instructions on re-labeling or replacement.
The recalled product
- Product
- MC-500 Multicolor Laser Photocoagulator; Distributed by NIDEK Inc. Manufactured by NIDEK CO., Ltd, Japan. For use in ophthalmic and retinal procedures.
- Manufacturer
- Nidek Inc
- Hazard
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 (20)
- Part number: 173530U20 Serial numbers: 50010
- 50127
- 50136
- 50277
- 50310
- 50311
- 50330
- 50331
- 50357. 50358
- 50359
- 50382
- 50383
- 50408. 50417
- 50418
- 50426
- 50439
- 50445
- 50446
- 50471
- 50514
Distribution
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