Imaging system software displays mirrored CT images during data loading
Siemens imaging systems with syngo VE20 software may display CT images mirrored horizontally and vertically when loading Toshiba data, potentially causing misinterpretation of patient positioning and inappropriate treatment.
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 Class II medical device recall involves a software error that creates a concrete risk of patient harm through diagnostic misinterpretation. No injuries or illnesses have been reported, but the error directly affects patient treatment decisions, making it a risk-of-harm product meeting the Score 3 (High) threshold.
Plain-English summary
Siemens Medical Solutions is recalling syngo Application software version VE20 (Material Number 10848815) installed on Artis imaging systems. This software runs on three system models: Artis pheno (Model 10849000), Artis icono biplane (Model 11327600), and Artis icono floor (Model 11327700). A total of 127 units have been distributed nationwide in the United States.
When loading computed tomography (CT) image data from Toshiba imaging systems, the recalled software can display images mirrored along the horizontal and vertical axes. This mirroring can cause medical professionals to misinterpret patient orientation and positioning, potentially resulting in inappropriate treatment. The risk persists even when the incorrect visualization is apparent to the user.
The recalled product
- Product
- syngo Application software VE20 (Material Number 10848815) installed on the Artis pheno and Artis icono systems as follows: (1) Artis pheno Model Number:10849000 (2) Artis icono biplane Model Number: 11327600 (3) Artis icono floor Model Number: 11327700
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Affected units
- 127
Distribution
Distributed nationwide across the United States.
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