Agency classClass IIOur severity:High FDA (Devices)·Z-1583-2015·Announced 2015-05-13

Siemens Axiom Aristos FX Radiography System Cable Cart Recall

Siemens is recalling 43 Axiom Aristos FX radiography systems because a cable cart defect could cause the cable holder to drop and hit patients or operators.

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: The recall involves a risk-of-harm product where injury has not yet been reported, fitting the criteria for a High severity score.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling 43 units of the Axiom Aristos FX Multipurpose Radiography System (MPRS). The recall is due to a defect where the cable cart and corrugated hose may be unable to move freely. If this occurs, the cable holder could drop down and hit patients or system operators.

The affected devices are identified by Model Number 7414803 and specific serial numbers listed in the recall notice. These systems were distributed nationwide. The MPRS is a dedicated x-ray system with a flat panel detector used for radiographic exposures of the whole body, excluding mammography.

Healthcare facilities should contact Siemens Medical Solutions USA, Inc. to arrange for the necessary corrective action. Patients and operators should be aware of the potential hazard if the equipment exhibits restricted movement in the cable cart area.

The recalled product

Product: AXIOM ARISTOS FX; Multipurpose Radiography System (MPRS) is a dedicated x-ray system with a flat panel detector which allows the acquisition of x-ray exposures without the use of conventional film/screen systems. The MPRS allows radiographic exposures of the whole body including…
Manufacturer: Siemens Medical Solutions USA, Inc
Category: Medical Device — Radiography System
Hazard: impact-injury
Affected units: 43

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)

Model Number of device: 7414803

Distribution

Distributed nationwide across the United States.

Same manufacturer · Siemens Medical Solutions USA, Inc

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