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[Recalled] GEHC OEC 8800 Mobile Fluoroscopic X-ray System, GE Healthcare, Surgery, Salt Lake City, UT. Mobile fluoroscopic examination of human anatomy. — X-ray units did not meet manufacturer's specification for linearity | FDA 2007-10-

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

ProductGEHC OEC 8800 Mobile Fluoroscopic X-ray System, GE Healthcare, Surgery, Salt Lake City, UT. Mobile fluoroscopic examination of human anatomy.
Brand / manufacturerGE OEC Medical Systems, Inc
Categorydevice
Issuing authorityFDA_DEVICE
ReferenceZ-2221-2012
Country of noticeUnited States
Risk levelClass II
Hazard typerecall
Notice date19 October 2007

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: X-ray units did not meet manufacturer's specification for linearity.

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 GE OEC Medical Systems, 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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