Class II
Medical Device Recall: Samsung Digital Diagnostic Mobile X-ray System, Model GM85.
NeuroLogica Corporation · December 28, 2023
Reason for Recall
Mobile x-ray systems moving arm frame welding issue which presents the potential of bodily harm due to fall of the arm.
Distribution
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.
States Affected
NATIONWIDE
Quantity Affected
261 devices
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1056-2024
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.