The Recall Desk
HighFDA (Devices)·Z-2185-2024·Announced 2024-07-03

AXIOM Vertix Solitaire Medical Imaging Device Recall: Fire Risk from Power Supply Defect

Siemens is recalling 4 AXIOM Vertix Solitaire medical imaging devices due to a short circuit in the touch display power supply that may cause overheating and fire. Units with serial numbers 1004, 1006, 1011, and 1014 are affected.

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 recall involves a fire hazard in a medical imaging device with no reported injuries or illnesses. Per the rubric, this qualifies as High (3) under the criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling the AXIOM Vertix Solitaire medical imaging device, a fluoroscopy system designed for examining emergency and accident patients in trauma settings and outpatient departments. Four units are affected, with serial numbers 1004, 1006, 1011, and 1014. The device has been distributed nationwide across the United States.

The recall is due to a short circuit in the power supply unit of the device's touch display. This short circuit may lead to overheating and fire, creating a safety hazard in clinical environments.

Healthcare facilities that operate this device should immediately stop using units matching the affected serial numbers and contact Siemens Medical Solutions for instructions on repair or replacement. Users should not operate the device until the issue has been resolved.

The recalled product

Product
AXIOM Vertix Solitaire - The Vertix MD Trauma has been specially designed for examining emergency and accident patients as well as for use in outpatient departments. Material Number: 8627718
Manufacturer
Siemens Medical Solutions USA, Inc
Category
Medical Device — Diagnostic Imaging Equipment
Hazard
Affected units
4

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)

  • UDI-DI: N/A Serial Numbers: 1004 1006 1011 1014

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 9 recalled by Siemens Medical Solutions USA, Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 9 products in this recall →

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Same manufacturer · Siemens Medical Solutions USA, Inc

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Same hazard · short circuit

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