FDA-Device2018-07-04Class II
ARTIS Pheno Interventional Fluoroscopic X-Ray System, Model 10849000
Siemens Medical Solutions USA, Inc
Hazard
If the C-arm is manually moved in the longitudinal direction to a fully extended position, the system's safety stop mechanism may be activated. As a result, the C-arm stops the movement and can drop up to 20 mm (0.8 ). Under certain circumstances, the cover of the detector or collimator can touch and possibly injure the patient due to the C-arm drop. This could lead to a situation in which it is necessary to stop the clinical treatment or continue the treatment on an alternative system.
Sold states
Healthcare facilities in AL, CA, CO, FL, IL, KY, MA, MI, MN, MS, NE, NJ, NY, OH, TN, TX, UT, and VA. Foreign distribution to Australia, Austria, Belgium, Denmark, France, Germany, Italy, Japan, Kuwait, Netherlands, Norway, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, and United Kingdom.
Affected count
39
Manufactured in
40 Liberty Blvd, Malvern, PA, United States
Products
ARTIS Pheno Interventional Fluoroscopic X-Ray System, Model 10849000
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2283-2018Don't want to check this manually?
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