—#187616

Product

Multitom RAX with software version VF10

FDA product code: OWB — Interventional Fluoroscopic X-Ray System
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K152928
Affected lot / code info: software version VF10 model# 10860700

Why it was recalled

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.

Root cause (FDA determination)

Software design

Action the firm took

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.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc
Address: 40 Liberty Blvd, Malvern, Pennsylvania 19355

Distribution

Distribution pattern: US Nationwide distribution

Timeline

Recall initiated: 2021-04-20
Terminated: 2023-11-08
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #187616. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.