PlainRecalls
FDA Devices Moderate Class II Ongoing

Samsung Digital Diagnostic Mobile X-ray System, Model GM85.

Reported: February 21, 2024 Initiated: December 28, 2023 #Z-1056-2024

Product Description

Samsung Digital Diagnostic Mobile X-ray System, Model GM85.

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.

Details

Recalling Firm
NeuroLogica Corporation
Units Affected
261 devices
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.
Location
Danvers, MA

Frequently Asked Questions

What product was recalled?
Samsung Digital Diagnostic Mobile X-ray System, Model GM85.. Recalled by NeuroLogica Corporation. Units affected: 261 devices.
Why was this product recalled?
Mobile x-ray systems moving arm frame welding issue which presents the potential of bodily harm due to fall of the arm.
Which agency issued this recall?
This recall was issued by the FDA Devices on February 21, 2024. Severity: Moderate. Recall number: Z-1056-2024.