Siemens ARTIS icono X-Ray Systems Recalled for Incorrect Vessel Quantification
Siemens is recalling five ARTIS icono X-ray systems because software may fail to detect vessels or provide incorrect measurements, potentially leading to wrong diagnoses.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk of incorrect diagnosis and inappropriate treatment, which aligns with the 'Severe' criteria for significant injury reports or high-risk medical device defects.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling five units of the ARTIS icono interventional Fluoroscopic X-Ray System (Model Number 11327600). The recall involves systems equipped with Quantification Application Software (QVA/QCA) on a standalone XWP computer. The affected serial numbers are 180014, 180015, 180018, 180019, and 180029.
The recall is due to a software defect where the Quantification Application may fail to detect blood vessels or provide incorrect quantification of vessel detection when used on DSA images. This malfunction could result in an incorrect diagnosis and inappropriate treatment of the patient.
The affected units were distributed in Arizona, Illinois, Utah, and Wisconsin. Healthcare facilities should contact Siemens Medical Solutions USA, Inc. for further instructions on how to address the software issue.
The recalled product
- Product
- ARTIS icono systems with Quantification Application SW (QVA/QCA) on a standalone XWP computer, an interventional Fluoroscopic X-Ray System Model Number: 11327600
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Affected units
- 5
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Serial Numbers: 180014 180015 180018 180019 180029
Distribution
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