Siemens Medical Solutions USA, Inc recalls system, x-ray, angiographic, model # 10094135, 10094137, 10094139, 10094141, 10280959 Artis zee/ zeego is a family of d…

Recall date

February 26, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1299-2016

FDA classification

Class II

Brand / firm

Siemens Medical Solutions USA, Inc

Sold / distributed

US Nationwide Distribution including states of: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, GU, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY, and PUERTO RICO.

Why it was recalled

In Artis zeego systems, angulations in the vicinity of the C-arm collision area can cause the cable inlet to become clamped and can result in mechanical damage. In Artis systems with A100Plus generators, an attempt to resume operation following detection of a fault (such as a short circuit in the X-ray tube) can result in the failure of a module in the high-voltage generator.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

system, x-ray, angiographic, model # 10094135, 10094137, 10094139, 10094141, 10280959 Artis zee/ zeego is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.