ARTIS Angiography Systems Recalled for Potential Radiation Overdose
Siemens ARTIS icono angiography systems with specific detector configurations may deliver higher radiation doses than intended in rare cases. The issue occurs during the first X-ray exposure after patient registration.
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: FDA Class II recall of a risk-of-harm medical device (diagnostic angiography system with potential for unintended radiation dose elevation). No injuries or illnesses have been reported; the hazard is theoretical and occurs only in very rare situations, meeting the rubric criterion for Score 3.
Plain-English summary
ARTIS is a family of angiography systems manufactured by Siemens AG/Siemens Healthcare GmbH used for diagnostic imaging and interventional procedures, including pediatric and obese patient applications. The recall specifically affects ARTIS icono systems equipped with a small detector and corresponding collimator (model #10843101).
In very rare situations, the first X-ray release following patient registration may be performed with incorrect copper prefiltration. When this occurs, the applied radiation dose rate may exceed the dose intended by the user.
The recall affects 201 units distributed worldwide, with US installations in Texas, Massachusetts, New Hampshire, Minnesota, Oklahoma, New Jersey, South Carolina, New York, Michigan, Illinois, Missouri, and North Carolina. Facilities with affected systems should contact Siemens for further information regarding this issue.
The recalled product
- Product
- ARTIS is 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.
- Manufacturer
- Siemens AG/Siemens Healthcare GmbH
- Hazard
- radiation-overdose
- equipment-malfunction
Distribution
Distributed nationwide across the United States.
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