Siemens AXIOM Artis and Artis zee Systems Recalled for X-Ray Release Issue
Siemens is recalling AXIOM Artis and Artis zee angiography systems because a hand switch defect may cause uncontrolled x-ray release.
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 (uncontrolled x-ray exposure) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 1,067 AXIOM Artis and Artis zee angiography systems. These dedicated diagnostic and interventional imaging systems are used for various procedures, including cardiac, neuro, and general angiography.
The recall is due to a potential problem with the hand switch operated at the patient table. This defect may result in the uncontrolled release of an x-ray image. 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 issue. The specific model numbers and material numbers for the affected units are listed in the official recall documentation.
The recalled product
- Product
- AXIOM Artis or Artis zee system Product Usage: Axiom Artis and Artis zee / zeego are 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
- Hazard
- Affected units
- 1,067
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 (18)
- material number 3771750
- model numbers: 5904441
- 5904466
- 7008605
- 7412807
- 7413078
- 7555357
- 7555365
- 7555373
- 7727717
- 7728392
- 10094135
- 10094137
- 10094139
- 10094141
- 10094142
- 10094143
- and 10280959
Distribution
Distributed nationwide across the United States.
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