Recall Z-0222-2015— Nidek Inc

Name: FDA recall Z-0222-2015
Creator: U.S. Food and Drug Administration
Published: 2013-05-24

Class II · Terminated

Class II FDA medical device recall by Nidek Inc, initiated 2013-05-24, terminated 2014-11-17. It names one FDA 510(k) clearance: K110228. Product: MC-500 Multicolor Laser Photocoagulator using software version 2.20. Opthalmic device used for retinal photocoagulation for treatment of ocular fundus diseases.. Reason: Retrospective review found that a Engineering Change Order initiated in May 2013 for a memory function problem was not reported as required..

Recalling firm: Nidek Inc
Classification: Class II
Status: Terminated
Initiated: 2013-05-24
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

MC-500 Multicolor Laser Photocoagulator using software version 2.20. Opthalmic device used for retinal photocoagulation for treatment of ocular fundus diseases.

Reason for recall

Retrospective review found that a Engineering Change Order initiated in May 2013 for a memory function problem was not reported as required.

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