X-Ray Imaging System X-Ray Tube Hardware Defect Worldwide Recall
Siemens has recalled Artis Q and Artis Q.zen X-ray imaging systems due to a potential X-ray tube hardware defect. In rare cases, if error detection fails, the system will not be able to release X-ray until shut down; 1,389 units are affected globally.
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: FDA Class II recall without reported hospitalizations or injuries. The hazard is a potential X-ray tube hardware defect that could impair error detection on medical imaging equipment. Per the rubric, Class II recalls without hospitalization reports on risk-of-harm products without reported injuries score at most 3 (High).
Plain-English summary
Siemens Medical Solutions USA, Inc. has recalled Artis Q, Artis Q.zen, Artis pheno, and Artis icono X-ray imaging systems due to a potential hardware issue with a specific lot of X-ray tubes.
In rare cases, if the error detection mechanism fails, the system will not be able to release X-ray until the system is shut down. This could prevent proper control of X-ray emission during imaging procedures.
Approximately 1,389 units of affected systems are distributed worldwide (590 in the US and 799 internationally) to numerous countries. Affected serial numbers are specified for Artis Q and Artis Q.zen variants.
Customers with affected serial numbers should contact Siemens Medical Solutions USA, Inc. for guidance on remediation options.
The recalled product
- Product
- Artis Q floor- Model No. 10848280 Artis Q ceiling- Model No. 10848281 Artis Q biplane- Model No. 10848282 Artis Q zeego- Model No. 10848283 Artis Q.zen floor- Model No. 10848353 Artis Q.zen ceiling- Model No. 10848354 Artis Q.zen biplane- Model No. 10848355
- Manufacturer
- Siemens Medical Solutions USA, Inc
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Siemens Medical Solutions USA, Inc 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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