FDA recall Z-1056-2024

Product

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.

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.

Key facts

Status

Ongoing

Initiation date

2023-12-28

Report date

2024-02-21

Voluntary/Mandated

Voluntary: Firm initiated

Location

Danvers, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1056-2024