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[Recalled] MC-500 Multicolor Laser Photocoagulator; Indicated for use in retinal photocoagulation for treatment of ocular fundus diseases like diabetic retinopathy, age-related macular degeneration, retinopathy of prematurity and retinal

recall fda device united-states

A safety authority has issued a recall or warning for this item. The confirmed facts from the source notice are laid out below.

Recall details

ProductMC-500 Multicolor Laser Photocoagulator; Indicated for use in retinal photocoagulation for treatment of ocular fundus diseases like diabetic retinopathy, age-related macular degeneration, retinopathy of prematurity and retinal detachment.
Brand / manufacturerNidek Inc
Categorydevice
Issuing authorityFDA_DEVICE
ReferenceZ-1127-2015
Country of noticeUnited States
Risk levelClass II
Hazard typerecall
Notice date27 March 2012

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: The spot size control of the scan delivery unit of the MC-500 Multicolor Laser Photocoagulator may turn by itself.

This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.

What to do if you own this product

Check whether your unit is affected and follow the authority's guidance before further use.

Read the full official notice →

Related recalls from Nidek Inc

This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.

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