Recall Z-2132-2014
Nidek Inc · initiated June 9, 2014
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
MC-500 Multicolor Laser Photocoagulator; Distributed by NIDEK Inc. Manufactured by NIDEK CO., Ltd, Japan. For use in ophthalmic and retinal procedures.
Codes / lots: Part number: 173530U20 Serial numbers: 50010, 50127, 50136, 50277, 50310, 50311, 50330, 50331, 50357. 50358, 50359, 50382, 50383, 50408. 50417, 50418, 50426, 50439, 50445, 50446, 50471, 50514, 50552, 50558, 50573, 50600, 50610, 50611, 50651.
Reason for recall
Laser aperture label was not affixed to device prior to shipment in the US.
FDA-determined cause: Error in labeling
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.
Details
- Recall number
- Z-2132-2014
- Initiated
- June 9, 2014
- Posted by FDA
- July 30, 2014
- Terminated
- November 24, 2014
- Product code
- HQF – Laser, Ophthalmic
- 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.
- Recalling firm
- Nidek Inc, Fremont, CA