FDA-Device2023-04-26Class II
Samsung GM85 Digital X-ray Imaging System-A Digital Diagnostic Mobile X-ray System
NeuroLogica Corporation
Hazard
Issue related to the operation of the arm latch within the column that supports the arm, potential bodily harm due to a fall of the arm
Sold states
US Nationwide distribution.
Affected count
935 units
Manufactured in
14 Electronics Ave, N/A, Danvers, MA, United States
Products
Samsung GM85 Digital X-ray Imaging System-A Digital Diagnostic Mobile X-ray System
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1414-2023Don't want to check this manually?
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