Agency classClass IIOur severity:High FDA (Devices)·Z-1150-2018·Announced 2018-03-28

Siemens AXIOM Artis angiographic x-ray systems recalled for coolant leaks

Siemens is recalling 22 AXIOM Artis angiographic x-ray systems because leaking coolant couplings can damage the flat panel detector, potentially requiring treatment cancellation or patient transfer.

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 is classified as FDA Class II. The hazard involves a risk of harm (treatment interruption or patient transfer) due to equipment failure, but no injuries or illnesses are reported in the source text, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling 22 units of the AXIOM Artis angiographic x-ray system, specifically model numbers 7412807, 7413078, and 7728392. The affected units are distributed in the United States across the states of Arizona, California, Florida, Iowa, Illinois, Louisiana, Michigan, North Carolina, New Jersey, Ohio, Oklahoma, and Texas.

The recall is due to a potential defect where plastic coolant couplings may leak. If this occurs, liquid can enter the flat panel detector, leading to a failure of the detector. This malfunction may necessitate the cancellation or restart of a medical treatment, or the transfer of the patient to an alternate or another system.

Healthcare facilities should identify affected units by checking the serial numbers listed in the official recall notice. Siemens is the recalling firm and is responsible for addressing the defect. No specific instructions for end-users are provided in the source text, as the product is a medical device used in clinical settings.

The recalled product

Product: AXIOM Artis angiographic x-ray system, Model Numbers: 7412807, 7413078, 7728392 AXIOM Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese…
Manufacturer: Siemens Medical Solutions USA, Inc
Category: Medical Device — Imaging Equipment
Hazard: equipment-failure
treatment-interruption
Affected units: 22

Distribution

Distributed in 12 states:

Same manufacturer · Siemens Medical Solutions USA, Inc

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