Siemens Artis Q Angiography Systems Recalled for Tabletop Movement Blockage
Siemens is recalling 459 Artis Q angiography systems because the floating tabletop may become blocked after a collision sensor activates.
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: The recall involves a medical device with a mechanical defect that could impede operation, fitting the 'High' criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 459 units of the Artis Q angiography system (material 10848280, 10848281, 10848282). The affected systems are dedicated angiography devices used for diagnostic imaging and interventional procedures, including cardiac, neuro, and general angiography.
The recall is due to a defect where the movement of the floating tabletop may be blocked after a collision sensor has been activated during system movement. This issue could potentially interfere with the operation of the imaging system.
The affected units were distributed worldwide, including nationwide distribution in the United States across multiple states. Siemens is the recalling firm. No specific instructions for consumers or healthcare providers are provided in the source text beyond the identification of the defect.
The recalled product
- Product
- Artis Q (material 10848280, 10848281, 10848282) - Product Usage: AXIOM Artis zee and Q/ Q.zen 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…
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Hazard
Distribution
Part of a larger recall action
This product is one of 4 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 4 products in this recall →Related recalls
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