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U.S. Department of Health and Human Services

Class 2 Device Recall Multitom RAX

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  Class 2 Device Recall Multitom RAX see related information
Date Initiated by Firm April 20, 2021
Create Date June 02, 2021
Recall Status1 Terminated 3 on November 08, 2023
Recall Number Z-1685-2021
Recall Event ID 87995
510(K)Number K152928  
Product Classification Interventional fluoroscopic x-ray system - Product Code OWB
Product Multitom RAX with software version VF10
Code Information software version VF10 model# 10860700
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
40 Liberty Blvd
Malvern PA 19355
For Additional Information Contact Anastasia Sokolova
610-219-4834
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 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 in Commerce 26
Distribution US Nationwide distribution
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = OWB and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.
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