FDA-Device2017-02-22Class II
ARTISTE MV System, medical charged-particle radiation therapy system Product Usage: The intended use of the SIEMENS branded PRIMUS family of linear accelerator systems is to deliver x-ray radiation for therapeutic treatment of cancer.
Siemens Medical Solutions USA, Inc
Hazard
Siemens became aware of Incorrect values for the rotational collimator position displayed due to mechanical problems of the sensor slide. In addition, there are improper weld seam at the overhead suspension.
Sold states
United States distribution
Affected count
194 systems
Manufactured in
40 Liberty Blvd, N/A, Malvern, PA, United States
Products
ARTISTE MV System, medical charged-particle radiation therapy system Product Usage: The intended use of the SIEMENS branded PRIMUS family of linear accelerator systems is to deliver x-ray radiation for therapeutic treatment of cancer.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1212-2017Don't want to check this manually?
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