Recall Z-2075-2014 ยท MUJ System, Planning, Radiation Therapy Treatment
Siemens Medical Solutions USA, Inc
Siemens syngo RT Dosimetrist 2.7 system Product Usage: The intended use of syngo Suite for Oncology Systems is as an accessory to the linear accelerator system to aid and support in the planning and delivery of x-ray radiation for the therapeutic treatment of cancer.
| Date | Jul 17, 2014 (initiated May 15, 2014) |
| Status | Terminated |
| Reason | An update to the Virtual Simulation software of the syngo RT Dosimetrist is necessary to address a safety issue. In special scenarios within the Structure Operations function the system did not store the selected name from the list of predefined names. After reloading of the data, this structure name had been changed by the system. Additionally, a performance issue was addressed where import of DI |
| Root cause | Software design |
| Action | Siemens sent a Medical Device Correction Field Safety Notice of Improvement letter to affected customers via USPS Certified Mail. The letter described the affected product, problem, and actions to be taken. |
| Quantity | 7 |
| Distribution | US Nationwide Distribution in the states of NH, TN, OH, VA, and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K101119 | SYNGO DOSIMETRIST WORKSPACE V2.7 MODEL: 1056864 Siemens Medical Solutions USA, Inc., Jun 16, 2010 |