Nidek Specular Microscope CEM-530 Software Recall for Unapproved Feature
Nidek Inc is recalling 29 Specular Microscope CEM-530 units because software versions 1.08 and 1.09 include an unapproved analysis feature.
- 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
- Category
- Medical Device
- Distribution
- 18 states