FDA Device recall Z-2711-2016
SPECULAR MICROSCOPE CEM-530
- FDA Device
- Class II
- terminated
- Published 2016-09-07
On 2016-09-07 the FDA classified a Class II recall of SPECULAR MICROSCOPE CEM-530 by Nidek, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2711-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-08-08 |
| Published | 2016-09-07 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Nidek |
| Distribution | AL, CA, CT, FL, IN, KS, KY, LA, MO, NM, NV, NY, OK, OR, PA, TN, TX, VA |
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 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.
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.
Identifiers
| code_info | Microscopes with serial numbers: 120004,120005, 120006, 120007, 120009, 120010, 120011,120012, 120013, 120014, 0120016…Microscopes with serial numbers: 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, 120050. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2711-2016%22
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