FDA-Device2012-10-10Class II

EOS X-ray Medical Diagnostic , X-ray Equipment System Digital Radiography used in general radiographic examination.

Eos Imaging Inc
Hazard

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.

Sold states
Nationwide distribution
Affected count
12 EOS Systems installed in the US
Manufactured in
185 Alewife Brook Pkwy Ste 410, N/A, Cambridge, MA, United States
Products
EOS X-ray Medical Diagnostic , X-ray Equipment System Digital Radiography used in general radiographic examination.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2072-2012

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