Nidek Specular Microscope Recalled for Electromagnetic Noise Exceeding Standards
Nidek, Inc. is recalling 13 Specular Microscopes, Model CEM-530, because their electromagnetic noise exceeded the upper limit of the Electromagnetic Compatibility Standard.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences. The issue is a technical compliance failure regarding electromagnetic noise limits rather than a direct physical hazard like fire or injury.
Plain-English summary
Nidek, Inc. is recalling 13 units of the NIDEK Specular Microscope, Model CEM-530. The device is used to provide noncontact, high magnification image capture of the endothelium, allowing for the observation of cell size and shape, as well as analysis of cell number, density, and area.
The recall was initiated because the electromagnetic noise of the devices exceeded the upper limit of the Electromagnetic Compatibility Standard (EMC: IEC 60601-1-2). The affected devices were distributed nationwide in the United States, specifically in the states of Arizona, California, Illinois, Kansas, Maryland, New Jersey, New York, Pennsylvania, South Carolina, and Virginia, as well as Puerto Rico.
The specific serial numbers for the recalled devices are 120080, 120081, 120086, 120087, 120088, 120090, 120091, 120092, 120093, 120094, 120095, 120096, and 170001. Users should contact Nidek, Inc. for further instructions regarding the recall.
The recalled product
- Product
- NIDEK Specular Microscope, Model CEM-530 - Product Usage: The device provides noncontact, high magnification image capture of endothelium enabling observation of the size and shape of cells. Information such as the number of endothelial cells, cell density, and cell area is analy
- Manufacturer
- Nidek, Inc.
- Affected units
- 13
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 (13)
- Serial numbers 120080
- 120081
- 120086
- 120087
- 120088
- 120090
- 120091
- 120092
- 120093
- 120094
- 120095
- 120096
- and 170001.
Distribution
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