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Siemens Medical Solutions USA, Inc recalls Artis zee floor, Artis Q ceiling, Artis Q.zen ceiling. Image-Intensified Fluoroscopic X-Ray System. Material numbers 108
Recalled November 25, 2020 · FDA recall Z-0469-2021 · Siemens Medical Solutions USA
Hazard
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 overvoltage situation occurs. · FDA Class II
Units
26 distributed worldwide (4 in US)
Sold at
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, and United Kingdom.
Description
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 overvoltage situation occurs.
Product
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.
Manufacturer(s)
Siemens Medical Solutions USA, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →