FDA-Device2019-06-05Class II
Samsung GM85 Mobile Digital X-ray Imaging System Product Usage: The GM85 Digital X-ray imaging System is 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
NeuroLogica Corporation
Hazard
Potential issue related to the operation of the safety latch within the column that supports the arm due to a possibility of potential bodily harm due to a fall of the arm in an unlikely event that the column wire breaks.
Sold states
US Nationwide Distribution
Affected count
288 systems
Manufactured in
14 Electronics Ave, N/A, Danvers, MA, United States
Products
Samsung GM85 Mobile Digital X-ray Imaging System Product Usage: The GM85 Digital X-ray imaging System is 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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1691-2019Don't want to check this manually?
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