Artis Systems with Software Artis VC20x/VC21A/VD10x that have a DSA license installed. Angiographic x-ray system

Reason: The firm has become aware of a potential issue on Artis systems with the software Artis VC20x/VC21A/VD10x that have a DSA license installed. Under certain preconditions, executing roadmap OGP (organ program) in the DSA overlay mode may lead to imprecise registration of the DSA mask image with the roadmap image displayed on the live monitor.

Code information: Model numbers 10094135, 10094137, 10094139, 10094141 and 10280959.

Distribution pattern: Nationwide Distribution including AL, CA, CO, FL, IA, IL, IN, KY, MA, MD, ME, MI, MN, MO, NC, ND, NJ, NY, OH, PA, SC, TX, UT, VA, WA, and WI and to Puerto Rico.