Siemens Artis Q Angiography Systems Recalled for Software Movement Issue
Siemens is recalling Artis Q angiography systems because a software issue could block stand and table movements.
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 is classified as FDA Class II, and the hazard involves a potential mechanical blockage in a medical device used for procedures, which poses a risk of harm even though no specific injuries are reported in the source text.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling specific models of the Artis Q angiography system, including the Biplane, Ceiling, Floor, and zeego variants. The recall involves 1,452 units worldwide, with 638 units distributed in the United States.
The recall is due to a software issue that could potentially cause the stand and table movements to be blocked. This defect affects the mechanical operation of the imaging systems used for diagnostic and interventional procedures.
Healthcare facilities should contact Siemens Medical Solutions USA, Inc. for instructions on how to resolve the software issue. The affected serial numbers are listed in the official recall documentation.
The recalled product
- Product
- Artis Q Biplane, Model No. 10848282; Artis Q Ceiling, Model No.10848281; Artis Q Floor, Model No. 10848280; Artis Q zeego, Model No. 10848283 Product Usage: Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and…
- 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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Similar recalls
- ModerateSiemens Artis Q Angiography Systems Recalled for Tabletop Movement Blockage
FDA (Devices) · 2019-05-22
- HighSiemens Artis Q. Angiography System Recalled for Potential Hardware Thermal Issue
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