Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1341-2019·Announced 2019-05-22

Siemens Artis Q Angiography Systems Recalled for Tabletop Movement Blockage

Siemens Medical Solutions is recalling 459 Artis Q angiography systems because the floating tabletop movement may be blocked after a collision sensor activates.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any injuries, illnesses, or deaths, fitting the criteria for a moderate severity recall involving a functional defect without reported harm.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling 459 units of the Artis Q angiography system (materials 10848280, 10848281, and 10848282). The affected systems are part of the AXIOM Artis zee and Q/ Q.zen family, which are dedicated angiography systems used for single and biplane diagnostic imaging and interventional procedures. These systems are used for various procedures including cardiac, neuro, and general angiography, as well as whole body radiographic and fluoroscopic procedures.

The recall is due to a defect where the movement of the floating tabletop may be blocked after a collision sensor has been activated during system movement. This issue affects the specific serial numbers listed in the recall documentation. The affected units were distributed worldwide, including nationwide distribution in the United States across multiple states such as Alabama, Arizona, California, Florida, and New York, as well as in foreign countries.

Hospitals and healthcare facilities using these systems should contact Siemens Medical Solutions USA, Inc. for further instructions on how to address the defect. The recall is classified as Class II by the FDA, indicating a situation where use of the product could, in some cases, cause temporary or medically reversible adverse health consequences.

The recalled product

Product: Artis Q (material 10848280, 10848281, 10848282) - Product Usage: AXIOM Artis zee and Q/ Q.zen 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 — Angiography System
Hazard: mechanical-failure

Distribution

Distributed nationwide across the United States.

The notice also names 33 states specifically:

Part of a larger recall action

This product is one of 4 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 4 products in this recall →

Same manufacturer · Siemens Medical Solutions USA, Inc

See all →

Moderate
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Same hazard · mechanical failure