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[Recalled] EOS X-ray Medical Diagnostic , X-ray Equipment System Digital Radiography used in general radiographic examination. — It was discovered of several generator failures of the EOS System due to failur… | FDA 2012-06-19

recall fda device united-states

The product on this page is subject to an official recall. We summarise the regulator's findings and the recommended action.

Recall details

ProductEOS X-ray Medical Diagnostic , X-ray Equipment System Digital Radiography used in general radiographic examination.
Brand / manufacturerEos Imaging Inc
Categorydevice
Issuing authorityFDA_DEVICE
ReferenceZ-2072-2012
Country of noticeUnited States
Risk levelClass II
Hazard typerecall
Notice date19 June 2012

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: It was discovered of several generator failures of the EOS System due to failure of its anode controller board that drives the rotation of the X-ray tube anode.

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 Eos Imaging 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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