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Terminated

Nidek MC-500 Multicolor Laser Photocoagulator using software version 2.20. Opthalmic Device. The Nidek Multicolor Laser photocoagulator Model MC-500 is indicated for use in retinal photocoagulation for treatment of ocular fundus diseases.

FDA Recall Z-0224-2015 · Posted 2014-11-17

Recalling FirmNidek Inc
Recall StatusTerminated
Product CodeHQF
Date Initiated2012-10-24
Date Terminated2014-11-17
Product Quantity21affected devices

Reason for Recall

When the MC-500 is turned on and coagulation is performed without changing the laser color, the delivery unit occasionally fails to emit the laser, or the power output is lower than the set program.

Firm Action

Nidek Field Service engineers visited each affected location to upgrade software.

Root Cause

Device Design

Distribution Pattern

US Distribution in the states of: NJ, SC, IL, MI, NY, CA, TX, OH, IN, UT, and MN.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K110228NIDEK MULTICOLOR LASER PHOTOCOAGULATORNidek Incorporated · 2011-02-23

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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