Nidek MC-500 Laser Photocoagulator Recalled for Unreported Engineering Change
Nidek Inc is recalling five MC-500 Multicolor Laser Photocoagulators because an engineering change order regarding a memory function problem was not reported as required.
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, but the source text does not report any illnesses, injuries, or deaths. The hazard is a regulatory compliance failure (failure to report an engineering change) rather than a direct, reported physical harm, fitting the 'Moderate' criteria for low-risk or voluntary/precautionary contexts where no harm is explicitly documented.
Plain-English summary
Nidek Inc is recalling five units of the MC-500 Multicolor Laser Photocoagulator, an ophthalmic device used for retinal photocoagulation to treat ocular fundus diseases. The recalled units are equipped with software version 2.20 and have serial numbers 50011, 50382, 50425, 50558, and 50609.
The recall was initiated after a retrospective review determined that an Engineering Change Order, initiated in May 2013 to address a memory function problem, was not reported to the FDA as required. This failure to report a significant change in the device's design or manufacturing process constitutes the basis for the recall.
The affected devices were distributed in the United States to the states of California, Nebraska, and New York. Users of these devices should contact Nidek Inc for further instructions regarding the recall and any necessary corrective actions.
The recalled product
- Product
- MC-500 Multicolor Laser Photocoagulator using software version 2.20. Opthalmic device used for retinal photocoagulation for treatment of ocular fundus diseases.
- Manufacturer
- Nidek Inc
- Category
- Medical Device — Ophthalmic
- Affected units
- 5
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 (6)
- MC-500
- Serial numbers: 50011
- 50382
- 50425
- 50558
- 50609
Distribution
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