The Recall Desk
ModerateFDA (Devices)·Z-0601-2017·Announced 2016-11-23

Siemens Artis Q Angiographic X-ray System Recalled for Footswitch Defect

Siemens is recalling 4,657 Artis Q angiographic x-ray systems because the semi-automatic focus switch may not work as intended when the footswitch is pressed multiple times.

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: The recall is classified as FDA Class II, and the source text explicitly states no injuries or illnesses have been reported, fitting the criteria for a moderate severity score involving a functional defect without reported harm.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling 4,657 Artis Q angiographic x-ray systems distributed nationwide in the United States. The recall involves specific model numbers: 10848280, 10848281, 10848282, 10848283, 10848353, 10848354, and 10848355.

The recall was initiated because the semi-automatic focus switch may not work as intended when the footswitch is pressed multiple times. The Artis Q systems are dedicated angiography systems used for diagnostic imaging and interventional procedures, including cardiac, neuro, and general angiography.

Healthcare facilities using these systems should contact Siemens Medical Solutions USA, Inc. for further instructions on how to address the defect. The source text does not report any injuries or illnesses associated with this recall.

The recalled product

Product
Artis Q, 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 that can
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 (7)

  • Model Numbers: 10848280
  • 10848281
  • 10848282
  • 10848283
  • 10848353
  • 10848354
  • 10848355

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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