Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0300-2022·Announced 2021-12-01

Siemens Artis Q floor angiography system: X-ray failure during SID lift operation

Siemens Artis Q floor angiography systems may fail to produce x-ray when SID lift movement is activated during x-ray release, resulting in procedural delays. The system displays an error message.

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: This is a FDA Class II recall with no reported injuries or illnesses. The documented issue is an operational/functional failure causing procedural delays, not a safety hazard with potential to cause patient harm. Per the rubric, Class II recalls without reported injuries typically score as Moderate.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling Artis Q floor with software VD12 angiography systems used for single and biplane diagnostic imaging and interventional procedures. Eight units are affected, identified by specific serial numbers.

The systems have a functional issue where x-ray imaging may not operate properly when the SID (source-to-image distance) lift movement is activated while x-ray release occurs simultaneously. When this condition occurs, the x-ray does not function and the system displays an error message stating 'No x-ray, try again.' This results in a short delay in procedures using affected systems.

Healthcare facilities with affected units should contact Siemens Medical Solutions for further guidance. Users of these systems should be aware of this operational limitation when both SID lift movement and x-ray release are activated at the same time.

The recalled product

Product: Artis Q floor with software VD12- angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number: 10848280
Manufacturer: Siemens Medical Solutions USA, Inc
Category: Medical Device — Angiography / Diagnostic Imaging
Hazard: device-malfunction
imaging-failure
Affected units: 8

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 10 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 10 products in this recall →

Same manufacturer · Siemens Medical Solutions USA, Inc

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