Z-2132-2014Class II

MC-500 Multicolor Laser Photocoagulator; Distributed by NIDEK Inc. Manufactured by NIDEK CO., Ltd, Japan. For...

Name: Z-2132-2014 MC-500 Multicolor Laser Photocoagulator; Distributed by NIDEK Inc. Manufactured by NIDEK CO., Ltd, Japan. For...
Creator: Nidek Inc
Published: 2014-06-09
License: https://open.fda.gov/license/

Nidek Incorporated / initiated 2014-06-09 / Terminated / root cause: labeling and UDI

FDA source

Nidek Inc began a recall of MC-500 Multicolor Laser Photocoagulator; Distributed by NIDEK Inc. Manufactured by NIDEK CO., Ltd, Japan. For use in ophthalmic and retinal procedures on 2014-06-09. FDA classified it as Class II and gives the reason as "Laser aperture label was not affixed to device prior to shipment in the US". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2132-2014
Classification: Class II
Status: Terminated
Initiated: 2014-06-09
Posted: 2014-07-30
Terminated: 2014-11-24
Recalling firm: Nidek Incorporated
Product: MC-500 Multicolor Laser Photocoagulator; Distributed by NIDEK Inc. Manufactured by NIDEK CO., Ltd, Japan. For use in ophthalmic and retinal procedures.
Product code: HQF Laser, Ophthalmic
Reason for recall: Laser aperture label was not affixed to device prior to shipment in the US.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
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.
Quantity in commerce: 29 units (26 already re-labeled)
Distribution: Nationwide Distribution including IL NE NY, NH, CD, MI, TX, CA, PA, FL, KS, UT, MN, WI,. MO. and OR.
Product codes and lots: Part number: 173530U20 Serial numbers: 50010, 50127, 50136, 50277, 50310, 50311, 50330, 50331, 50357. 50358, 50359, 50382, 50383, 50408. 50417, 50418, 50426, 50439, 50445, 50446, 50471, 50514, 50552, 50558, 50573, 50600, 50610, 50611, 50651.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2132-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2132-2014	Class II	Terminated	Voluntary: Firm initiated	2014-08-06	2014-07-30

Product code HQF

K110228Class IINidek Multicolor Laser PhotocoagulatorNidek Incorporated / cleared 2011-02-23

Process control is the most common named cause of a device recall11 SEP 2026 / by Medical Device Manufacturing

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)