MC-500 Multicolor Laser Photocoagulator; Distributed by NIDEK Inc. Manufactured by NIDEK CO., Ltd, Japan. For use in ophthalmic and retinal procedures.
This recall has been terminated (originally issued July 30, 2014).
- Company
- Nidek Inc
- Recall Initiated
- June 9, 2014
- Posted
- July 30, 2014
- Terminated
- November 24, 2014
- Recall Number
- Z-2132-2014
- Quantity
- 29 units (26 already re-labeled)
- Firm Location
- Fremont, CA
- Official Source
- View on FDA website ↗
Reason for Recall
Laser aperture label was not affixed to device prior to shipment in the US.
Distribution
Nationwide Distribution including IL NE NY, NH, CD, MI, TX, CA, PA, FL, KS, UT, MN, WI,. MO. and OR.
Lot / Code Info
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.
Root 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.