FDA-Device2024-02-21Class II
Samsung Digital Diagnostic Mobile X-ray System, Model GM85.
NeuroLogica Corporation
Hazard
Mobile x-ray systems moving arm frame welding issue which presents the potential of bodily harm due to fall of the arm.
Sold states
US Nationwide Distribution including states of: AL, AR, CA, CO, CT, DC, FL, GA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, PA, SD, TN, TX, VA, WI & WV.
Affected count
261 devices
Manufactured in
14 Electronics Ave, N/A, Danvers, MA, United States
Products
Samsung Digital Diagnostic Mobile X-ray System, Model GM85.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1056-2024Don't want to check this manually?
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