Z-0224-2015Class II

Nidek MC-500 Multicolor Laser Photocoagulator using software version 2.20. Opthalmic Device. The Nidek...

Name: Z-0224-2015 Nidek MC-500 Multicolor Laser Photocoagulator using software version 2.20. Opthalmic Device. The Nidek...
Creator: Nidek Inc
Published: 2012-10-24
License: https://open.fda.gov/license/

Nidek Incorporated / initiated 2012-10-24 / Terminated / root cause: design

FDA source

Nidek Inc began a recall of Nidek MC-500 Multicolor Laser Photocoagulator using software version 2.20. Opthalmic Device. The Nidek Multicolor Laser photocoagulator Model MC-500 is... on 2012-10-24. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0224-2015
Classification: Class II
Status: Terminated
Initiated: 2012-10-24
Posted: 2014-11-17
Terminated: 2014-11-17
Recalling firm: Nidek Incorporated
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.
Product code: HQF Laser, Ophthalmic
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.
Root cause tag: design
FDA root cause: Device Design
Action: Nidek Field Service engineers visited each affected location to upgrade software.
Quantity in commerce: 21affected devices
Distribution: US Distribution in the states of: NJ, SC, IL, MI, NY, CA, TX, OH, IN, UT, and MN.
Product codes and lots: Model MC-500 Serial numbers: 50277 50310 50330 50331 50357 50358 50383 50408 50417 50418 50425 50426 50439 50440 50445 50446 50471 50514 50311 50359 50382,

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0224-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0224-2015	Class II	Terminated	Voluntary: Firm initiated	2014-11-26	2014-11-17

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)