Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0457-2019·Announced 2018-11-21

Siemens Artis zee Biplane Systems Recalled for C-Arm Vibration Issues

Siemens is recalling 14 Artis zee biplane systems because C-arm vibrations may reduce image quality due to a ceiling support screw connection.

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 hazard involves reduced image quality rather than direct physical injury or death, fitting the criteria for moderate severity.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling 14 units of the Artis zee biplane system, specifically those with Material 10094141. These are dedicated angiography systems used for diagnostic imaging and interventional procedures, including cardiac, neuro, and general angiography.

The recall is issued because vibrations of the C-arm on plane B may result in reduced image quality. This issue is caused by the screw connection to the C-arm in the ceiling support. The affected units were distributed nationwide in the United States.

Healthcare facilities should contact Siemens Medical Solutions USA, Inc. for instructions on how to address the defect. The specific serial numbers for the affected units are 155122, 155149, 155151, 155105, 155148, 154671, 155126, 155131, 155132, 155119, 155121, 155118, and 155147.

The recalled product

Product: ARTIS zee biplane systems with Material 10094141- a Angiographic x-ray system Product Usage: Artis zee is a dedicated angiography system 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: reduced-image-quality
mechanical-vibration
Affected units: 14

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 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 3 products in this recall →

Same manufacturer · Siemens Medical Solutions USA, Inc

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