CLASS II Device recall · Reported 26 Nov 2014 · FDA Enforcement Report

MC-500 Multicolor Laser Photocoagulator using recalled by Nidek

Nidek is recalling MC-500 Multicolor Laser Photocoagulator using, distributed in California, Nebraska, New York. The recall was initiated on 24 May 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesMC-500; Serial numbers: 50011, 50382, 50425, 50558, 50609

Quantity recalled5

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0222-2015
FDA event ID: 69531
Recalling firm: Nidek, Fremont, CA
Classification: Class II
Status: Terminated
Recall initiated: 24 May 2013
FDA classified: 17 Nov 2014
Reported: 26 Nov 2014
Type: Voluntary: Firm initiated
Customers notified by: Visit
Reason category: Device Malfunction
Device type: Medical Software

Timeline

24 May 2013	Recall initiated by company
17 Nov 2014	Classified by FDA	+542 days
26 Nov 2014	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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

Where it was distributed

US Distribution in the states of: CA, NE, and NY.

California Nebraska New York

Questions about this recall

Is MC-500 Multicolor Laser Photocoagulator using recalled?

Yes. Nidek recalled MC-500 Multicolor Laser Photocoagulator using on 24 May 2013. The recall is Class II and its status is Terminated. Recall number Z-0222-2015.

Why was it recalled?

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

Which lots are affected?

MC-500; Serial numbers: 50011, 50382, 50425, 50558, 50609

Where was it sold?

US Distribution in the states of: CA, NE, and NY.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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