Nidek Specular Microscope CEM-530 Software Recall for Unapproved Feature

Plain-English summary

Nidek Inc is recalling 29 units of the Specular Microscope CEM-530. The recall involves devices running software versions 1.08 and 1.09. These devices are used for non-contact, high-magnification image capture of the corneal endothelium to analyze cell density and area for surgical and postoperative follow-up.

The recall was initiated because the software versions included a change to the analysis results feature that was not reviewed and approved by the FDA. The affected devices were distributed in the United States to the states of Texas, Kansas, Florida, Nevada, California, Pennsylvania, Kentucky, Oregon, Tennessee, Alabama, Virginia, Missouri, Oklahoma, Connecticut, New York, Louisiana, New Mexico, and Indiana.

Healthcare facilities and users should identify affected devices by checking the serial numbers listed in the recall notice. The specific serial numbers affected are: 120004, 120005, 120006, 120007, 120009, 120010, 120011, 120012, 120013, 120014, 0120016, 120019, 120021, 120023, 120024, 120026, 120030, 120036, 0120038, 120039, 120040, 120042, 120044, 120045, 120046, 120047, 120048, 120049, and 120050. Users should contact Nidek Inc for instructions on how to proceed with the recall.

The recalled product

Product

SPECULAR MICROSCOPE CEM-530; Software version 1.08 and 1.09. Opthalmic: The 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 endothelia

Manufacturer

Nidek Inc

Category

Medical Device — Ophthalmic Imaging

Hazard

• unapproved-feature

Affected units

29

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

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