The Recall Desk
ModerateFDA (Devices)·Z-1342-2022·Announced 2022-07-13

Siemens X-ray System Fan Wear May Cause Equipment Malfunction

Siemens is recalling 88 Artis Icono X-ray systems in the U.S. due to increased fan wear that could lead to electrical failure and malfunction of the imaging system during operation.

What this means for you

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 no reported hospitalizations, injuries, or adverse events. The hazard is a theoretical electrical failure in medical equipment based on observed fan wear during testing. Per the rubric, Class II recalls without reported harm and purely theoretical hazards are classified as moderate.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling the Artis Icono Interventional Fluoroscopic X-Ray System, Model No. 11327600. The company has identified 88 units in the United States and 195 units worldwide affected by this issue.

During system tests, increased wearing of the image acquisition system fans was observed. This wear could lead to electrical failure, which may cause malfunction of the imaging system during regular operation. No adverse events or injuries have been reported to date.

Healthcare providers using affected equipment should contact Siemens Medical Solutions USA, Inc. for servicing and guidance. Patients and providers should not discontinue use without consulting with Siemens or their medical device representative.

The recalled product

Product
Artis Icono, Interventional Fluoroscopic X-Ray System, Model No. 11327600
Manufacturer
Siemens Medical Solutions USA, Inc
Category
Medical Device — Diagnostic Imaging / X-ray System
Hazard

Distribution

Distributed in 32 states:

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