FDA-Device2014-01-29Class II
PRIMUS, ONCOR, ARTISTE Linac systems with component 550 TxT Treatment Table. TT-A, TT-D, TT-M or TT-S Table tops. Manufactured by: SIEMENS AG, MEDICAL SOLUTIONS Roentgenstrasse 19-21 Kemnath, GERMANY 95478 The intended use of the SIEMENS branded, ARTISTE", ONCOR" and PRIMUS" family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.
Siemens Medical Solutions USA, Inc
Hazard
Update to correct the possibility for patients or operators to have their fingers trapped or pinched between the table top and the bottom frame of the 550 TxT Treatment Table. Combined with this update instruction is a second complaint issue related to an incident in which a cable inside of the TxT" Treatment Table has been damaged due to contacting a moving part. The resulting short-circuit cau
Sold states
Worldwide Distribution: US (nationwide) and internationally to: Canada, Italy, P.R. China, Argentina, Pakistan, South Africa, Egypt, Iran, Vietnam, Indonesia, Brazil, Hungary, Bulgaria, India, Spain, Switzerland, Trinidad, Tobago, Italy, Algeria, Croatia, Turkey, Japan, Germany, Portugal, Poland, France, Sri Lanka, Russian Federation, France, Lebanon, Slovakia, Ukraine, Pakistan, and Korean Republic.
Affected count
305 active devices.
Manufactured in
757 Arnold Dr Ste A, Martinez, CA, United States
Products
PRIMUS, ONCOR, ARTISTE Linac systems with component 550 TxT Treatment Table. TT-A, TT-D, TT-M or TT-S Table tops. Manufactured by: SIEMENS AG, MEDICAL SOLUTIONS Roentgenstrasse 19-21 Kemnath, GERMANY 95478 The intended use of the SIEMENS branded, ARTISTE", ONCOR" and PRIMUS" family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0787-2014Don't want to check this manually?
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