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NeuroLogica Corporation recalls Samsung GU60A system- Digital X-ray Imaging Systems are intended for use in generating radiographic images of human ana
Recalled September 6, 2017 · FDA recall Z-3036-2017 · NeuroLogica
Hazard
When performing the Stitching function on GU60A system, unintended area is exposed to radiation · FDA Class II
Units
87 units
Sold at
Nationwide Distribution
Description
When performing the Stitching function on GU60A system, unintended area is exposed to radiation
Product
Samsung GU60A system- Digital X-ray Imaging Systems are intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications
Manufacturer(s)
NeuroLogica Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →