Artis zee floor, Artis Q ceiling, Artis Q.zen ceiling. Image-Intensified Fluoroscopic X-Ray System. Material numbers 10848281, 10848354, 10094135, 10848354 - Product Usage: Artis 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.

Recall Insight

This FDA Devices action (record #Z-0469-2021) was formally reported on November 25, 2020, with the manufacturer initiating the action on October 21, 2020. It is classified under Moderate severity (Class II), with a current status of Terminated. Siemens Medical Solutions USA, Inc is listed as the recalling firm, operating out of Malvern, PA. Federal records list the affected scope as 26 distributed worldwide (4 in US).

The documented reason for this recall is: Some electronic components within the generator were equipped with an incorrect protection diode. As a result, protection against overvoltage may be inadequate, and the system may not function properly in the event an o… Distribution data in the federal record shows the product reached: Worldwide distribution - US Nationwide distribution including in the states of AR, CA, IA, IL and the countries of China, Germany, India, Indonesia, Italy, Japan, Philippines, Saudi Arabia, South Korea, Taiwan, Turkey, …. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.