SPECULAR MICROSCOPE CEM-530; Software version 1.08 and 1.09. Opthalmic: The NIDEK Specular Microscope CEM-530 provides n
FDA device recall Z-2711-2016 · posted 2016-09-01 · Terminated
Recall details
- Recalling firm
- Nidek Inc
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Software change control
- Status
- Terminated
- Product code
- NQE
- Quantity affected
- 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.
- Date initiated
- 2016-08-08
- Date posted
- 2016-09-01
- Date terminated
- 2017-01-09
- Location
- Fremont, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Specular Microscope CEM- 530 (K151706) | Nidek Co., Ltd. | 2016-03-17 |