The Recall Desk
HighFDA (Devices)·Z-1685-2021·Announced 2021-06-09

Multitom RAX imaging system software addresses beam alignment and dose calculation issues

Siemens is recalling Multitom RAX imaging systems (software version VF10) due to rare software issues affecting beam alignment and radiation dose calculations.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall of a medical device with potential risks from radiation dose miscalculation and beam misalignment. Although no illnesses or injuries have been reported and the hazards are mitigated by visual indicators or extreme rarity, the potential for unintended radiation exposure qualifies this as a risk-of-harm product where injury has not yet been reported, meeting the High severity criterion.

Plain-English summary

Siemens Medical Solutions is recalling the Multitom RAX imaging system with software version VF10. The FDA classified this as a Class II recall. Approximately 26 units were distributed nationwide in the United States.

The recall addresses two software-related issues. First, under certain operating conditions (when a wall mode organ program without top alignment is selected, the system is moved to the centered position, top alignment is activated, collimation is increased, and the tube is lifted), the system may allow image acquisition even when more than 20 percent of the X-ray beam does not strike the detector. Although the misalignment is typically visible via the light field and operators are unlikely to trigger this condition, the possibility exists for the tube to be misaligned by more than 20 percent from the detector position.

Second, in very rare cases using a free exposure organ program, the system may calculate an incorrect radiation dose value that exceeds the 2 Gy safety limit. This occurs when the system incorrectly uses too small a source-to-image distance for dose calculation, causing the calculated dose to significantly exceed the actual applied dose. As a result, the dose limit alarm (buzzer) activates erroneously rather than providing accurate notification.

Facilities operating this system should contact Siemens Medical Solutions USA, Inc. for instructions on obtaining and implementing the necessary software correction.

The recalled product

Product
Multitom RAX with software version VF10
Manufacturer
Siemens Medical Solutions USA, Inc
Category
Medical Device — Diagnostic Imaging
Hazard
  • beam-misalignment
  • radiation-dose-miscalculation

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • software version VF10 model# 10860700

Distribution

Distributed nationwide across the United States.

Related recalls

Same category