Samsung Digital Diagnostic Mobile X-ray System, Model GM85.
Recall
- Recall Number
- Z-1056-2024
- Event Number
- 93803
- Firm
- NeuroLogica Corporation
- FEI Number
- 3004938766
- Product Code
- IZL
- Status
- Open, Classified
- Root Cause
- Process design
- Initiated
- December 28, 2023
- Posted
- February 9, 2024
- Address
- 14 Electronics Ave, Danvers, MA, 01923-1011
Description
Samsung Digital Diagnostic Mobile X-ray System, Model GM85.
Mobile x-ray systems moving arm frame welding issue which presents the potential of bodily harm due to fall of the arm.
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.
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.
261 devices