Siemens ARTIS Pheno X-Ray System Recalled for Potential Hardware Thermal Issue
Siemens Medical Solutions USA is recalling 605 ARTIS Pheno interventional fluoroscopic X-ray systems due to a potential hardware issue that may cause thermal effects and damage to system parts.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves potential hardware damage and thermal effects, but the source text does not report any injuries, illnesses, or hospitalizations, fitting the criteria for a moderate severity score.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 605 units of the ARTIS Pheno Model 10849000 Interventional Fluoroscopic X-Ray System. The recall is due to a potential hardware issue that may cause thermal effects and possible damage to system parts.
The affected systems were distributed nationwide in the United States. The product is a dedicated angiography system used for diagnostic imaging and interventional procedures, including cardiac, neuro, and general angiography, as well as whole-body radiographic and fluoroscopic procedures.
The source text does not specify specific actions for consumers or healthcare providers, nor does it report any injuries or illnesses associated with this recall.
The recalled product
- Product
- ARTIS Pheno Model 10849000. Interventional Fluoroscopic X-Ray System Product Usage: Artis 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
- 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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