High FDA (Devices)·Z-1534-2017·Announced 2017-03-29

Siemens ARTIS Q x-ray systems recalled for potential high-voltage generator failure

Siemens is recalling 264 ARTIS Q interventional fluoroscopic x-ray systems because a component in the A100G generator can age and fail.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II and involves a potential mechanical failure of a high-voltage generator module. Per the rubric, risk-of-harm products where injury has not yet been reported are classified as High (3).

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling 264 units of the ARTIS Q Interventional Fluoroscopic x-ray system. The recall affects 112 units distributed in the United States and 152 units distributed worldwide. The affected systems are identified by specific model and serial numbers listed in the agency's recall record.

The recall is due to a component in the A100G high-voltage generator that can be affected by aging. This aging could result in the potential failure of a module within the high-voltage generator. The source text does not report any specific injuries, illnesses, or deaths associated with this defect.

Healthcare facilities and users should contact Siemens Medical Solutions USA, Inc. for instructions on how to address the potential generator failure. 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, Interventional Fluroscopic x-ray system
Manufacturer: Siemens Medical Solutions USA, Inc
Category: Medical Device — Imaging Equipment
Hazard: electrical-failure
component-aging

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 (6)

Model # 10848280
10848281
10848282
10848283
10848353
10848354

Distribution

Distribution scope not specified by the agency.

Same manufacturer · Siemens Medical Solutions USA, Inc

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