Reported Sep 7, 2016 · Terminated
SPECULAR MICROSCOPE CEM-530; Software version 1.08 and 1.09. Opthalmic: The NIDEK Specular Microscope CEM-530 provides…
Nidek Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Nidek Inc · 47651 Westinghouse Dr · Fremont, CA · 94539-7474
Is this the product you have?
SPECULAR MICROSCOPE CEM-530Software version 1.08 and 1.09
- OpthalmicThe NIDEK Specular Microscope CEM-530 provides non-contact, 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 analyzed through the captured images. The captured images and analysis results of endothelium are used for intraocular or corneal surgery, postoperative follow-up and corneal observation such as for endothelial disorders or the corneal state of patients who wear extended-wear contact lenses
- Lot codes and dates
- Microscopes with serial numbers
12000412000512000612000712000912001012001112001212001312001401200161200191200211200231200241200261200301200360120038120039120040120042120044120045120046120047120048120049120050
- Microscopes with serial numbers
- Amount recalled
- 29 affected devices
Where it was sold
Why it was recalled
Software version 1.08 and 1.09 for the Specular Microscope CEM 530 included a change of analysis results feature that was not reviewed and approved by the FDA.
This product could cause temporary or reversible health problems — stop using it.
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