Multitom RAX with software version VF10
Enforcement
- Recall Number
- Z-1685-2021
- Event ID
- 87995
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Siemens Medical Solutions USA, Inc
- Voluntary / Mandated
- FDA Mandated
- Initial Notification
- Letter
- Report Date
- June 9, 2021
- Initiation Date
- April 20, 2021
- Classification Date
- June 2, 2021
- Termination Date
- November 8, 2023
- Address
- 40 Liberty Blvd, Malvern, PA, 19355, United States
Description
Multitom RAX with software version VF10
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 highly unlikely for the operator to trigger the examination as the misalignment is visible due to the light field being out of range. AND In very rare cases it may occur that the calculated dose value exceeds the limit of 2 Gy. This may potentially occur only when an organ program for free exposure is selected, and the system uses incorrect (too small) source-to-image distance (SID) for calculating applied dose. Hence, the calculated dose is much higher than the actual applied dose causing the buzzer, which normally notifies the operator about the exceeded limit of 2 Gy, to get activated erroneously.
software version VF10 model# 10860700
US Nationwide distribution
26