PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: May 8, 2013 Initiated: April 4, 2013 #Z-1182-2013

Product Description

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.

Reason for Recall

Software update to fix multiple safety related issues.

Details

Units Affected
245 active devices
Distribution
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.
Location
Martinez, CA

Frequently Asked Questions

What product was recalled?
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.. Recalled by Siemens Medical Solutions USA, Inc. Units affected: 245 active devices.
Why was this product recalled?
Software update to fix multiple safety related issues.
Which agency issued this recall?
This recall was issued by the FDA Devices on May 8, 2013. Severity: Moderate. Recall number: Z-1182-2013.