ARTIS pheno interventional x-ray system software defect prevents treatment continuation
Siemens is recalling ARTIS pheno x-ray systems with VE10B software due to three potential software issues that may prevent continued treatment on the affected system, potentially requiring use of an alternate system.
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: This is a FDA Class II recall of a medical device used in patient treatment. No hospitalizations or injuries have been reported. The hazard is potential treatment interruption (risk-of-harm where injury has not yet been reported), which meets the criteria for Score 3.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling ARTIS pheno interventional fluoroscopic x-ray systems (Model No. 10849000) due to three potential software issues affecting systems with VE10B software. The recall includes 140 units distributed nationwide in the United States and internationally.
The identified software issues may prevent treatment from continuing on the affected system. This may necessitate continuing patient treatment on an alternate system.
Healthcare facilities operating these systems should verify their device serial number against the recall list and contact Siemens for further guidance regarding the identified issues and any necessary remediation steps.
The recalled product
- Product
- ARTIS pheno, Interventional fluoroscopic x-ray system, Model No. 10849000
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Affected units
- 140
Distribution
Distributed nationwide across the United States.
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