Siemens Artis Medical Imaging Systems Recalled for Radiation Safety Defect
Siemens is recalling Artis zee, Artis Q, and Artis Pheno systems because the Air Kerma Rate can exceed regulatory limits when frame rates are increased during continuous release.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, and the defect involves exceeding regulatory radiation limits, which constitutes a significant safety hazard.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling specific models of Artis zee, Artis Q, and Artis Pheno medical imaging systems. The recall involves 5,602 units distributed worldwide and in the United States.
The recall is due to a defect where the measured Air Kerma Rate can exceed regulatory limits. This occurs when a user changes frame rates from a lower frequency (e.g., 10 f/s) to a higher frequency (e.g., 30 f/s) during the continuous release of the Fluoro Override function.
The affected models include various configurations of the Artis zee, Artis zeego, Artis Pheno, Artis Q, and Artis Q.zen systems. Specific model numbers are listed in the recall documentation. Healthcare facilities should contact Siemens Medical Solutions USA, Inc. for instructions on how to address this issue.
The recalled product
- Product
- Artis zee/ zeego & Artis Q/ Q.zen Artis Pheno
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Category
- Medical Device — Imaging Systems
- Hazard
- Affected units
- 5,602
Distribution
Distributed nationwide across the United States.
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