ARTISTE, ONCOR and PRIMUS

Model: , Affected:

Radiology Equipment

System IVK no. Component Component IVK Ser #  ARTISTE MV system 8139789 550 TxT table 7346534 d1894 ONCOR Expression 7360717 550 TxT table 7346534 d1894 ONCOR Impression 5857912 550 TxT table 7346534 d1894 Plus ONCOR Impression 5857920 550 TxT table 7346534 d1894 ONCOR Avant Garde 5863472 550 TxT table 7346534 d1894 PRIMUS HI 4504200 550 TxT table 7346534 d1894 PRIMUS Mid-Energy 1940035 550 TxT table 7346534 d1894

Radiology Devices

2

No

Worldwide Distribution - USA (nationwide) including P.R and the countries of: Africa, Angola, Argentina, Australia, Austria, Belgium, Bosnia, Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia, Egypt, France, Germany, Greece, Hungary, India, Indonesia, Italy, Japan, Kuwait, Lebanon, Malaysia, Mexico, Myanmar, Netherlands, New Zealand, Norway, Pakistan, Philippines, Poland, Portugal, Republic of Korea, Russian Federation, Saudi Arabia, Serbia, South Thailand, Sri Lanka, Spain, Switzerland, Trinidad, Tobago, Turkey, Ukraine and United Kingdom, .

Siemens-branded linear accelerator with a 550 TxT Treatment Table with a serial number <_ 1894. Siemens brand ARTISTE, ONCOR and PRIMUS Linear Accelerator systems include the 550 TxT" Treatment Table. || Manufactured by: SIEMENS AG, MEDICAL SOLUTIONS || Roentgenstrasse 19-21 || Kemnath, GERMANY 95478. || Product Usage: || 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.

Syngo RT Therapist RTT 4.2.108; part number 8162815: Syngo ST Theratpist Connect RTT 4.2.108; part number 8168754

Radiology Devices

2

No

Worldwide Distribution - USA (nationwide) and internationally to Poland, India, Canada, Germany, United Kingdom, New Zealand, Belgium, Malaysia, Republic Korea, Ireland, Australia, Norway, Japan, Turkey, Croatia, Saudi Arabia, Colombia, P.R. China, Brazil, Thailand, Romania, Lebanon, Mexico, Italy, Sweden, Czech Republic, Russian Federation, and South Africa.

Software correction applies to customers who use the RT Therapist RTT4.2.108 and RT Therapist Connect RTT 4.2.108 || on Siemens ARTISTE, ONCOR and PRIMUS systems. || ARTISTE, ONCOR and PRIMUS family of linear accelerators are used to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.