The Recall Desk
HighFDA (Devices)·Z-2528-2024·Announced 2024-08-14

Multitom Rax X-Ray Systems Support Arm May Lower Unexpectedly

The support arm on Siemens Multitom Rax X-ray systems may unintentionally lower, creating a fall risk to people positioned beneath the ceiling-mounted display during system positioning.

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 risk-of-harm medical device where no illnesses or injuries have been reported. The hazard is potential injury from falling equipment, making it a preventive recall that meets the criteria for High severity.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling the Multitom Rax X-ray imaging system (Model Number 10860700) due to a potential safety hazard.

The support arm holding the display may unintentionally lower without warning. If this occurs while a person is positioned underneath the ceiling-mounted or wall-suspended display during system setup or repositioning, it could result in injury.

The Multitom Rax is used in clinical settings to visualize anatomical structures by converting X-ray patterns into visible images. The system is distributed nationwide in the United States.

If you own or operate a Multitom Rax system, immediately discontinue use of the equipment in the affected configuration and contact Siemens Medical Solutions USA, Inc. for guidance on remedial measures.

The recalled product

Product
Multitom Rax -Intended to visualize anatomical structures by converting an x-ray pattern into a visible image Model Number: 10860700
Manufacturer
Siemens Medical Solutions USA, Inc
Hazard
  • falling-equipment
  • impact-injury

Distribution

Distributed nationwide across the United States.