Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0302-2022·Announced 2021-12-01

Siemens Artis Q Biplane X-ray System Software Imaging Delay Issue

Siemens Medical Solutions is recalling 15 Artis Q biplane diagnostic x-ray systems due to a software issue in the VD12-angiography subsystem. When source-to-image distance lift is activated simultaneously with x-ray release, the system fails to activate and displays an error message, causing procedural delay.

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 classification indicates moderate concern. No injuries or illnesses have been reported. The source explicitly describes the consequence as a procedural delay rather than a direct safety or health risk, which places this at Moderate severity per the rubric for low-risk operational issues without reported injury potential.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling 15 Artis Q biplane diagnostic imaging systems (Model 10848282) distributed nationwide in the United States. These systems are used for single and biplane diagnostic imaging and interventional procedures.

The recalled systems have a software issue affecting the VD12-angiography subsystem. When source-to-image distance (SID) lift movement is activated simultaneously with x-ray release, the x-ray does not activate. Instead, the system displays the message "No x-ray, try again," which may result in a short delay in the procedure.

The recall affects 15 units with the following serial numbers: 122025, 122012, 122022, 122021, 122005, 121209, 122017, 122001, 134500, 122010, 122007, 122016, 122013, 122024, and 122014.

Healthcare facilities using affected units should contact Siemens Medical Solutions for instructions. The FDA classified this as a Class II recall.

The recalled product

Product: Artis Q biplane with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number: 10848282
Manufacturer: Siemens Medical Solutions USA, Inc
Category: Medical Device — Diagnostic Imaging / X-ray System
Hazard: equipment-malfunction
imaging-delay
Affected units: 15

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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