FDAFDA · Food and drugs·Recall number Z-0222-2015
MC-500 Multicolor Laser Photocoagulator using software version 2.20. Opthalmic device used for retinal photocoagulation for treatment of ocular fundus diseases.
Published November 26, 2014 · Recall initiated: May 24, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Retrospective review found that a Engineering Change Order initiated in May 2013 for a memory function problem was not reported as required.
What to do
Voluntary: Firm initiated · Visit
Recall details
- Manufacturer
- Nidek Inc
- Distributor
- US Distribution in the states of: CA, NE, and NY.
- Lot
- MC-500; Serial numbers: 50011, 50382, 50425, 50558, 50609
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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