Recall Z-2711-2016 ยท NQE Microscope, Specular
Nidek Inc
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 endothelial cells, cell density, and cell area is analyzed through the captured images. The captured images and analysis results of
| Date | Sep 1, 2016 (initiated Aug 8, 2016) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Software change control |
| Action | The firm, Nidek, sent a Dear Doctor letters entitled "RECALL NOTIFICATION" dated August 15, 2016 to affected sites by Federal Express. The letter informs users of the issue and stated that Nidek field service representatives will visit to install updated software. If you have any questions, please call Customer Service at 1-800-722-0219; Monday-Friday 8am to 5pm PST or email: cem530update@noritsuservice.com. |
| Quantity | 29 affected devices |
| Distribution | US Distribution to states of: TX, KS, FL, NV, CA, PA, KY, OR, TN, AL, VA, MO, OK, CT, NY. LA, NM, and IN. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K151706 | Specular Microscope CEM- 530 Nidek Co., Ltd., Mar 17, 2016 |