Siemens Diagnostic Angiography System Recalled for Multiple Software Defects
Siemens is recalling its Artis pheno diagnostic angiography system (12 units) due to four software defects that may prevent imaging, corrupt images, or cause unintended shutdowns during clinical use.
What this means for you
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 an FDA Class II recall of a diagnostic medical imaging system with four software defects that could result in measurement errors, loss of imaging capability, image corruption, or unintended system shutdown. While no illnesses or injuries have been reported, these functional defects present a risk of diagnostic error or procedural interruption, meeting the rubric criterion for high-severity risk-of-harm products without reported injury.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling the Artis pheno diagnostic imaging angiography system, model 10849000, with software version VE20C. The recall affects 12 units distributed nationwide in the United States. The specific serial numbers involved are: 164719, 164712, 164722, 164723, 164728, 164711, 164718, 164703, 164721, 164726, 164724, and 164725.
The recall has been issued due to four identified software defects: (1) updated calibration data is not saved after measurement adjustments, which may result in inaccurate measurements; (2) the system may not generate x-ray images and require shutdown and restart during interventional procedures; (3) images may become corrupted during the roadmap imaging mode; and (4) the imaging system may shut down unexpectedly when the uninterruptible power supply (UPS) option is installed. These defects can compromise the system's diagnostic capability and functionality during clinical use.
Healthcare facilities with affected Artis pheno systems should contact Siemens Medical Solutions USA, Inc. for information regarding software updates or corrective actions. This recall has been classified as a Class II recall by the FDA.
The recalled product
- Product
- Artis pheno with software VE20C- diagnostic imaging angiography system Model: 10849000
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Hazard
- measurement-error
- image-corruption
- imaging-failure
- system-shutdown
Distribution
Distributed nationwide across the United States.
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