Siemens ARTIS Angiography Systems May Deliver Unintended Radiation Doses
Siemens ARTIS icono angiography systems with certain detectors may deliver higher-than-intended radiation doses in rare cases. The issue occurs when incorrect copper prefiltration is applied during initial 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 medical device with potential for increased radiation exposure in patients. Source explicitly states no illnesses or injuries reported and the defect occurs in 'very rare situations,' but unintended radiation dose escalation on a medical imaging system constitutes a risk-of-harm scenario that warrants High severity.
Plain-English summary
Siemens has issued a recall for the ARTIS icono family of angiography systems equipped with a small detector and matching collimator (model 10843101). These are medical imaging systems used for diagnostic and interventional procedures in patients of varying sizes, including pediatric and obese patients.
In very rare situations, the first x-ray exposure following patient registration may be performed with incorrect copper prefiltration. When this occurs, the radiation dose rate delivered to the patient may be higher than the user intended.
A total of 201 ARTIS icono systems are affected by this recall, distributed worldwide and throughout the United States (including Texas, Massachusetts, New Hampshire, Minnesota, Oklahoma, New Jersey, South Carolina, New York, Michigan, Illinois, Missouri, and North Carolina). Customers are instructed to contact Siemens for further guidance and corrective measures.
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
- calibration-error
Distribution
Distributed nationwide across the United States.
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