Siemens Artis Q. Angiography System Recalled for Potential Hardware Thermal Issue
Siemens Medical Solutions is recalling 605 Artis Q. angiography systems due to a potential hardware issue that may cause thermal effects and damage to system parts.
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: The recall involves a risk-of-harm product (medical device) where injury has not yet been reported, fitting the 'High' severity criteria for potential damage without confirmed adverse health consequences.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 605 units of the Artis Q. angiography system, including models 10848280, 10848281, 10848282, 10848283, 10848353, 10848354, and 10848355. These systems are used for single and biplane diagnostic imaging and interventional procedures, including cardiac, neuro, and general angiography.
The recall is being conducted due to a potential hardware issue that may cause thermal effects and possible damage to system parts. The affected units were distributed nationwide in the United States.
Healthcare facilities should identify affected units by checking the model and serial numbers listed in the recall notice. Siemens Medical Solutions is the recalling firm and is responsible for addressing the hardware issue.
The recalled product
- Product
- Artis Q. angiography system. Model 10848280, 10848281, 10848282, 10848283, 10848353, 10848354 & 10848355 Product Usage: Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not l
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Affected units
- 605
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 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.
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