Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0296-2022·Announced 2021-12-01

Medical Imaging System May Fail to Release X-rays Under Specific Conditions

Siemens Artis zee floor angiography systems may fail to release x-rays when the SID lift and x-ray functions are activated simultaneously, causing procedural delay. Three units 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 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: FDA Class II recall with software malfunction causing procedural delay. Source text does not report any illnesses, injuries, deaths, or serious adverse events. The hazard is operational inconvenience rather than a reported safety risk.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling Artis zee floor angiography systems with software VD12 (Model 10094135) distributed nationwide. When the SID (source-to-image distance) lift movement is activated and an x-ray is simultaneously released, the x-ray function fails to operate and displays the message "No x-ray, try again," resulting in a short delay in the procedure.

This Class II recall affects three units with serial numbers 124703, 139012, and 139023. The issue is a software malfunction that occurs only when both SID lift and x-ray functions are triggered at the same time, preventing the x-ray from being released during that specific circumstance.

Healthcare facilities operating these systems should be aware of this condition and take appropriate measures to avoid simultaneous activation of the SID lift and x-ray functions during procedures.

The recalled product

Product: Artis zee floor with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number: 10094135
Manufacturer: Siemens Medical Solutions USA, Inc
Category: Medical Device — Angiography / Diagnostic Imaging
Hazard: software-malfunction
device-failure
x-ray-failure
Affected units: 3

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)

Serial Numbers: 124703 139012 139023

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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Same hazard · software malfunction