Z-1685-2021Class II

Multitom RAX with software version VF10

Name: Z-1685-2021 Multitom RAX with software version VF10
Creator: Siemens Medical Solutions USA, Inc
Published: 2021-04-20
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2021-04-20 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of Multitom RAX with software version VF10 on 2021-04-20. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1685-2021
Classification: Class II
Status: Terminated
Initiated: 2021-04-20
Posted: 2021-06-02
Terminated: 2023-11-08
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Multitom RAX with software version VF10
Product code: OWB Interventional Fluoroscopic X-Ray System
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.
Root cause tag: software
FDA 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 in commerce: 26
Distribution: US Nationwide distribution
Product codes and lots: software version VF10 model# 10860700

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1685-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1685-2021	Class II	Terminated	FDA Mandated	2021-06-09	2021-06-02

Product code OWB

K152928Class IIMultitom RaxSiemens Medical Solutions USA, Inc. / cleared 2015-11-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)