MC-500 Multicolor Laser Photocoagulator; Distributed by NIDEK Inc. Manufactured by NIDEK CO., Ltd, Japan. For use in ophthalmic and retinal procedures.
FDA Recall Z-2132-2014 · Posted 2014-07-30
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Recalling FirmNidek Inc
Recall StatusTerminated
Product CodeHQF
Date Initiated2014-06-09
Date Terminated2014-11-24
Product Quantity29 units (26 already re-labeled)
Reason for Recall
Laser aperture label was not affixed to device prior to shipment in the US.
Firm 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.
Root Cause
Error in labeling
Distribution Pattern
Nationwide Distribution including IL NE NY, NH, CD, MI, TX, CA, PA, FL, KS, UT, MN, WI,. MO. and OR.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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