Agency classClass IIOur severity:High FDA (Devices)·Z-2188-2024·Announced 2024-07-03

Siemens AXIOM Vertix Solitaire Display Fire Risk from Power Supply Short Circuit

Siemens is recalling the AXIOM Vertix Solitaire diagnostic imaging component due to a short circuit in the Touch Display's power supply unit that may cause overheating and fire. Two units with serial numbers 1239 and 1241 are affected.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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 involving a potential fire hazard from a power supply short circuit in a medical device. No injuries or illnesses have been reported; the hazard remains theoretical, consistent with High severity criteria.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling the ZE for Vertix Solitaire (AXIOM Vertix Solitaire), a diagnostic imaging component. The device is designed for examining emergency and accident patients and for use in outpatient departments. Two units are affected, identified by serial numbers 1239 and 1241.

A potential short circuit exists in the power supply unit (PSU) of the Touch Display component. This defect may cause overheating and create a fire risk.

The affected units were distributed nationwide across the United States.

The recalled product

Product: ZE for Vertix Solitaire - The AXIOM Vertix Solitaire is a component and has been specially designed for examining emergency and accident patients as well as for use in outpatient departments Material Number: 5901900
Manufacturer: Siemens Medical Solutions USA, Inc
Category: Medical Device — Diagnostic Imaging
Hazard: fire
overheating
electrical-failure
Affected units: 2

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: 1239 1241

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 →

Same manufacturer · Siemens Medical Solutions USA, Inc

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