Recall Z-2132-2014— Nidek Inc

Name: FDA recall Z-2132-2014
Creator: U.S. Food and Drug Administration
Published: 2014-06-09

Class II · Terminated

Class II FDA medical device recall by Nidek Inc, initiated 2014-06-09, terminated 2014-11-24. It names one FDA 510(k) clearance: K110228. Product: MC-500 Multicolor Laser Photocoagulator; Distributed by NIDEK Inc. Manufactured by NIDEK CO., Ltd, Japan. For use in ophthalmic and retinal procedures.. Reason: Laser aperture label was not affixed to device prior to shipment in the US..

Recalling firm: Nidek Inc
Classification: Class II
Status: Terminated
Initiated: 2014-06-09
Terminated: 2014-11-24
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; Distributed by NIDEK Inc. Manufactured by NIDEK CO., Ltd, Japan. For use in ophthalmic and retinal procedures.

Reason for recall

Laser aperture label was not affixed to device prior to shipment in the US.

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