Recall Z-1182-2013 ยท IYE Accelerator, Linear, Medical
Siemens Medical Solutions USA, Inc
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.
| Date | Apr 26, 2013 (initiated Apr 4, 2013) |
| Status | Terminated |
| Reason | Software update to fix multiple safety related issues. |
| Root cause | Software design |
| Action | Siemens sent updated instructions of TH004/13/S on April 4, 2013. The SW Update will be delivered by the Siemens Customer Service Group. For questions regarding this recall call 925-293-5442. |
| Quantity | 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, |
| FDA record | Open on fda.gov |