Recall Z-2216-2011 ยท IYE Accelerator, Linear, Medical
Siemens Medical Solutions USA, Inc
ARTISTE , ONCOR and PRIMUS accelerators that utilize the RT Therapist v4.2 system in combination with syngo RT Oncologist 4.2. The ONCOR and PRIMUS may be updated to utilize the RT Therapist v4.2 software. The RT Oncologist v4.2 is currently only on Non-US systems. Distributed by Siemens Healthcare, Concord, CA 94520 Intended use: Radiation therapy
| Date | May 19, 2011 (initiated Mar 31, 2011) |
| Status | Terminated |
| Reason | Siemens has become aware of a potential safety issue that may result in mistreatment when customers are configured with the ARTISTE Linac RT Therapist v4.2 in combination with RT Oncologist v.4.2 and use the remote "Online 2D Image Review. |
| Root cause | Software design |
| Action | The firm, Siemens, sent an "Urgent: Medical Device Correction Customer Safety Advisory Notice" on March 31, 2011 via Siemens Customer Service Group or certified mail to its customers. The notice describes the product, problem and actions to be taken. The customers were instructed to not use the "Online 2D Image Review" on the Syngo RT Oncologist 4.2; to always calculate the offset directly on the RTT 4.2 before it is applied for the treatment with the patient on the treatment table; include this notice in their syngo RT Therapist 4.2 System Owner Manual chapter "Safety Advisory Letter" where |
| Quantity | 45 active devices |
| Distribution | Worldwide distribution: USA (nationwide) including states of: CA, FL, OH, PA and UT; and countries including: Australia, Belgium, Croatia, Germany, Japan, South Africa, Sweden and United Kingdom. |
| FDA record | Open on fda.gov |