FDA-Device2018-04-25Class II
Solid state x-ray imager (flat panel/digital imager) Solid state x-ray imager (flat panel/digital imager) Medical
NeuroLogica Corporation
Hazard
While transporting the portable machine with the retrofit equipment in a backwards motion, there is potential for foot injury from the underside of the detector bin of the retrofit unit.
Sold states
US Distribution . Only one consignee was shipped 16 units of the affected device.
Affected count
16 units
Manufactured in
14 Electronics Ave, Danvers, MA, United States
Products
Solid state x-ray imager (flat panel/digital imager) Solid state x-ray imager (flat panel/digital imager) Medical
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1391-2018Don't want to check this manually?
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