Recall Z-3005-2020 ยท MUJ System, Planning, Radiation Therapy Treatment
Siemens Medical Solutions USA, Inc
Software: Syngo.via RT Image Suite software version VA30_SP02 with license T_RT_IMAGE_SUITE_PAT_MARK Intended Use: used as an advanced application on a SOM10 scanner SMN: 10496180
| Date | Aug 19, 2020 |
| Status | Terminated |
| Reason | Calibration offset between the central CT image plane and the external RT lasers has been set automatically to the factory default of 50.00 cm, if the misadjustment of the offset value is not recognized during the subsequent treatment planning process or remains undetected during the position verification at the treatment system (e.g. linear accelerator), this can potentially result in an incorrect dose or dose applied to the wrong location |
| Root cause | Software design |
| Action | Siemens Medical Solutions USA, Inc. issued Customer Safety Advisory Letter (CSAN) SY051/20/S on August 19, 2020 via email/hand delivery by Siemens Customer Service Engineer,. The letter states reason for recall, health risk and action to take: we highly recommend performing the laser calibration and the quality assurance procedure for the laser offset after every RT Image Suite software update.Please update the calibration offset in the MM RT Image Suite Configuration dialog accordingly . Details of this procedure are documented in Chapter 13.2 (Laser configuration) of your user manual. If y |
| Quantity | 64 systems US |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K192065 | Syngo.Via RT Image Suite Siemens Medical Solutions USA, Inc., Sep 18, 2019 |