Siemens ARTIS Angiography Systems Recalled for Excessive Radiation Dose
Siemens is recalling ARTIS angiography systems where the first X-ray after patient registration may use incorrect copper prefiltration, potentially resulting in higher radiation doses than intended.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: This is an FDA Class II medical device recall for a risk-of-harm condition (potential radiation overdose in rare situations) with no reported illnesses or injuries, which per the rubric qualifies as High severity.
Plain-English summary
Siemens is recalling ARTIS angiography systems equipped with small detectors and corresponding collimators (model #10843101). These dedicated systems are used for diagnostic imaging and interventional procedures, including applications in pediatric and obese patients.
A potential issue was identified where the first X-ray release following patient registration may be performed with incorrect copper prefiltration. In very rare situations, this could result in an applied radiation dose rate higher than intended by the user.
The recall affects 201 units distributed worldwide. In the United States, affected units are located in Texas, Massachusetts, New Hampshire, Minnesota, Oklahoma, New Jersey, South Carolina, New York, Michigan, Illinois, Missouri, and North Carolina.
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
- Affected units
- 201
Distribution
Part of a larger recall action
This product is one of 3 recalled by Siemens AG/Siemens Healthcare GmbH 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 →Related recalls
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