Recall Z-2132-2014 ยท HQF Laser, Ophthalmic
Nidek Inc
MC-500 Multicolor Laser Photocoagulator; Distributed by NIDEK Inc. Manufactured by NIDEK CO., Ltd, Japan. For use in ophthalmic and retinal procedures.
| Date | Jul 30, 2014 (initiated Jun 9, 2014) |
| Status | Terminated |
| Reason | Laser aperture label was not affixed to device prior to shipment in the US. |
| Root cause | Error in labeling |
| Action | 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. |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K110228 | NIDEK MULTICOLOR LASER PHOTOCOAGULATOR Nidek Incorporated, Feb 23, 2011 |