Samsung Digital Diagnostic Mobile X-ray System, Model GM85.
FDA Recall Z-1056-2024 · Posted 2024-02-09
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Recalling FirmNeuroLogica Corporation
Recall StatusOpen, Classified
Product CodeIZL
Date Initiated2023-12-28
Product Quantity261 devices
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.
Firm Action
An "Urgent - Medical Device Correction" notice was issued via email on December 28, 2023, cosigned by representatives of Samsung Electronics Co., Ltd. and NeuroLogica Corp. The notice describes the product, problem and actions to taken. The customers were instructed to continue to use the GM85 systems and Service Engineers will contact you to arrange for on-site correction. Share this notice with users within your organization or anywhere the devices may have been transferred. Customer Reply Form are to be completed and returned via email to [email protected]. Contact your local representative with questions email: [email protected], 1-800-976-0980.
Root Cause
Process design
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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