The Recall Desk
HighFDA (Devices)·Z-0603-2017·Announced 2016-11-23

Siemens AXIOM Artis Angiographic X-ray Systems Recalled for Footswitch Defect

Siemens is recalling AXIOM Artis angiographic x-ray systems because the semi-automatic focus switch may fail when the footswitch is pressed multiple times.

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 involves a risk-of-harm product (medical device) where the defect could impact patient safety during procedures, but no injuries have been reported, fitting the criteria for a High severity score.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling 4,657 AXIOM Artis angiographic x-ray systems worldwide. The recall is due to a defect where the semi-automatic focus switch may not work as intended when the footswitch is pressed multiple times.

These systems are used for diagnostic imaging and interventional procedures, including cardiac and neuro angiography. The affected units are distributed nationwide in the US. The specific model numbers involved are 5917054, 7008605, 7412807, 7413078, 7555357, 7555365, 7555373, 7727717, and 7728392.

Healthcare facilities should contact Siemens Medical Solutions USA, Inc. for instructions on how to resolve the issue. The source text does not report any injuries or illnesses associated with this defect.

The recalled product

Product
AXIOM Artis, Angiographic x-ray system Product Usage: The Artis systems are a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures tha
Manufacturer
Siemens Medical Solutions USA, Inc
Category
Medical Device — Imaging Equipment
Hazard
Affected units
4,657

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 (9)

  • Model Numbers: 5917054
  • 7008605
  • 7412807
  • 7413078
  • 7555357
  • 7555365
  • 7555373
  • 7727717
  • 7728392

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 →

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