Z-0222-2015Class II

MC-500 Multicolor Laser Photocoagulator using software version 2.20. Opthalmic device used for retinal...

Name: Z-0222-2015 MC-500 Multicolor Laser Photocoagulator using software version 2.20. Opthalmic device used for retinal...
Creator: Nidek Inc
Published: 2013-05-24
License: https://open.fda.gov/license/

Nidek Incorporated / initiated 2013-05-24 / Terminated / root cause: software

FDA source

Nidek Inc began a recall of MC-500 Multicolor Laser Photocoagulator using software version 2.20. Opthalmic device used for retinal photocoagulation for treatment of ocular fundus diseases on 2013-05-24. FDA classified it as Class II and gives the reason as "Retrospective review found that a Engineering Change Order initiated in May 2013 for a memory function problem was not reported as required". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0222-2015
Classification: Class II
Status: Terminated
Initiated: 2013-05-24
Posted: 2014-11-17
Terminated: 2014-11-17
Recalling firm: Nidek Incorporated
Product: MC-500 Multicolor Laser Photocoagulator using software version 2.20. Opthalmic device used for retinal photocoagulation for treatment of ocular fundus diseases.
Product code: HQF Laser, Ophthalmic
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.
Root cause tag: software
FDA root cause: Software design
Action: Nidek Engineers visited all affected sites to install new software version. For questions regarding this recall call 510-353-7785.
Quantity in commerce: 5
Distribution: US Distribution in the states of: CA, NE, and NY.
Product codes and lots: MC-500; Serial numbers: 50011, 50382, 50425, 50558, 50609

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0222-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0222-2015	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)