The FDA announced on March 30, 2021, that Siemens Medical Solutions USA, Inc. is recalling Artis angiography systems due to corrosion risks. The agency issued recall number Z-1496-2021 for the voluntary Class II recall affecting approximately 3,320 units distributed nationwide.
How to tell if you have it
- Brand: Siemens
- Product: AXIOM Artis FC (Material # 05904433)
- Product: AXIOM Artis FA (Material # 05904441)
- Product: AXIOM Artis MP (Material # 05904466)
- Product: AXIOM Artis BC (Material # 05904649)
- Product: AXIOM Artis BA (Material # 05904656)
- Product: AXIOM Artis dBC Mag. Nav. (Material # 05917054)
- Product: AXIOM Artis TA (Material # 07007755)
- Product: AXIOM Artis dTA (Material # 07008605)
- Product: AXIOM Artis dFC (Material # 07412807)
- Product: AXIOM Artis dTC (Material # 07413078)
- Product: AXIOM Artis dBA (Material # 07555357)
- Product: AXIOM Artis dMP (Material # 07555365)
- Product: AXIOM Artis dFA (Material # 07555373)
- Product: AXIOM Artis dFC Mag. Nav. (Material # 07727717)
- Product: AXIOM Artis TC (Material # 07728350)
- Product: AXIOM Artis dBC (Material # 07728392)
- Product: Artis zee floor (Material # 10094135)
- Product: Artis zee ceiling (Material # 10094137)
- Product: Artis zee MP (Material # 10094139)
- Product: Artis zee biplane (Material # 10094141)
- Product: Artis zee floor MN (Material # 10094142)
- Product: Artis zee biplane MN (Material # 10094143)
- Product: Artis Q floor (Material # 10848280)
- Product: Artis Q ceiling (Material # 10848281)
- Product: Artis Q biplane (Material # 10848282)
- Product: Artis Q.zen floor (Material # 10848353)
- Product: Artis Q.zen ceiling (Material # 10848354)
- Product: Artis Q.zen biplane (Material # 10848355)
- Distribution: US Nationwide
- Units affected: 3,320
The hazard
According to the FDA, inappropriate cleaning has caused unexpected corrosion of visible belts in some Artis systems. This corrosion may lead to belt malfunction, resulting in limited functionality or system failure. Unintended movement of the C-Arm could create hazardous situations for patients, operators, or staff and necessitate canceling or continuing treatment on an alternative system.
Context
GovInfoNow's records show Siemens Medical Solutions USA, Inc. has issued 182 other recalls since June 6, 2017. Recent similar recalls include the Siemens ARTIS icono Ceiling Monitor Recall (June 8, 2026), the Siemens ARTIS Icono Biplane Recall (May 20, 2026), and the Siemens ARTIS Pheno VE30A/VE40A recall (March 12, 2026). Other recent recalls of similar products include the Steris AMSCO 7052HP Washer/Disinfector Recall (Nov. 19, 2025), the GE Optima XR200amx Mobile Radiography System Recall (June 5, 2026), and the Canon Alphenix X-ray Systems Recall (Aug. 4, 2026).