Recall Z-1685-2021 ยท OWB Interventional Fluoroscopic X-Ray System
Siemens Medical Solutions USA, Inc
Multitom RAX with software version VF10
| Date | Apr 20, 2021 |
| Status | Terminated |
| Reason | Siemens identified two issues, In some cases, it is possible to perform an image acquisition although more than 20% of the beam does not hit the detector. This may only occur when an organ program for the wall mode without top alignment is selected and the system is moved to the centred position. If afterwards the operator activates the top alignment, increases the collimation, and lifts the tube, the system allows examination even with the tube being misaligned to the detector position. Hence, it is possible to overshoot the detector by more than 20%. From a clinical point of view, it is high |
| Root cause | Software design |
| Action | Siemens Healthineers sent an Urgent Medical Device Correction letters dated March 20, 2021 to all affected customers. The letter identified the affected product, problem and actions to be taken. Siemens Healthineers will issue a software correction (VF11C) that will eliminate both issues. The software solution will be distributed remotely via Update Instructions XP006/21/P. |
| Quantity | 26 |
| Distribution | US Nationwide distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K152928 | Multitom Rax Siemens Medical Solutions USA, Inc., Nov 13, 2015 |