Recall Z-0224-2015— Nidek Inc

Name: FDA recall Z-0224-2015
Creator: U.S. Food and Drug Administration
Published: 2012-10-24

Class II · Terminated

Class II FDA medical device recall by Nidek Inc, initiated 2012-10-24, terminated 2014-11-17. It names one FDA 510(k) clearance: K110228. Product: 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.. Reason: 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..

Recalling firm: Nidek Inc
Classification: Class II
Status: Terminated
Initiated: 2012-10-24
Terminated: 2014-11-17
Firm location: Fremont, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K110228 — NIDEK MULTICOLOR LASER PHOTOCOAGULATORNidek Incorporated·cleared 2011-02-23

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.