MC-500 Multicolor Laser Photocoagulator; Distributed by NIDEK Inc. Manufactured by NIDEK CO., Ltd, Japan. For use in oph
FDA device recall Z-2132-2014 · posted 2014-07-30 · Terminated
Recall details
- Recalling firm
- Nidek Inc
- Reason for recall
- Laser aperture label was not affixed to device prior to shipment in the US.
- Action taken
- Nidek sent a Recall/Field Correction letter dated June 9, 2014, to all affected customers. The letter advised customers of the issues and informed customers that Nidek Representatives will visit each location to affix the proper labeling to the device. Customers with questions were instructed to contact Nidek Customer Service at 1-800-223-9044 M-F 8 am to 5 pm PST. For questions regarding this recall call 510-353-7785.
- Root cause
- Error in labeling
- Status
- Terminated
- Product code
- HQF
- Quantity affected
- 29 units (26 already re-labeled)
- Distribution
- Nationwide Distribution including IL NE NY, NH, CD, MI, TX, CA, PA, FL, KS, UT, MN, WI,. MO. and OR.
- Date initiated
- 2014-06-09
- Date posted
- 2014-07-30
- Date terminated
- 2014-11-24
- 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 |
|---|---|---|
| NIDEK MULTICOLOR LASER PHOTOCOAGULATOR (K110228) | Nidek Incorporated | 2011-02-23 |