Home / Recalls / Medical Devices
Siemens Medical Solutions USA, Inc recalls ARTIS pheno-Angiography systems developed for single and biplane diagnostic imaging and interventional procedures. Mate
Recalled August 16, 2023 · FDA recall Z-2361-2023 · Siemens Medical Solutions USA
Hazard
Due to a hardware issue in the cable connectors of the system generator, a thermal overload in the cable connections may occur when performing excessive fluoroscopy/acquisitions, a burning smell may be detectable coming from the generator cabinet and the system may lose the imaging functionality of the corresponding plane and result in a situation where it is necessary to cancel clinical treatment or to continue treatment on an alternative system · FDA Class II
Units
10 units
Sold at
Worldwide distribution - US Nationwide and the countries of Algeria, Australia, Austria, Belgium, Chile, China, Czech Republic, Denmark, Finland, France, Germany, Guadeloupe, Hong Kong, India, Indonesia, Italy, Japan, Latvia, Luxembourg, Macedonia, Mexico, Monaco, Netherlands, New Zealand, Norway, Poland, Qatar, Romania, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom.
Description
Due to a hardware issue in the cable connectors of the system generator, a thermal overload in the cable connections may occur when performing excessive fluoroscopy/acquisitions, a burning smell may be detectable coming from the generator cabinet and the system may lose the imaging functionality of the corresponding plane and result in a situation where it is necessary to cancel clinical treatment or to continue treatment on an alternative system
Product
ARTIS pheno-Angiography systems developed for single and biplane diagnostic imaging and interventional procedures. Material Number: 10849000
Manufacturer(s)
Siemens Medical Solutions USA, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →