Diagnostic Imaging Angiography System Software Defects Recalled by Siemens
Siemens is recalling 23 Artis icono angiography systems due to four software defects that could disable imaging, corrupt images, and cause unexpected shutdowns during patient procedures.
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: FDA Class II recall of medical imaging equipment with potential risk-of-harm from software defects that could disable critical imaging functions and cause unintended shutdowns during patient interventions. No reported injuries or illnesses to date.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 23 units of the Artis icono floor diagnostic imaging angiography system (Model 11327700, software version VE20C) distributed nationwide due to four potential software issues.
The affected systems may experience: calibration data not being properly saved after measurement adjustments, loss of x-ray imaging capability that may require system restart during patient procedures, image corruption during roadmap imaging functions, and unintended system shutdown on units equipped with an Uninterruptable Power Supply.
These software issues could result in interrupted imaging during critical patient interventions, loss of diagnostic capability, and unexpected system shutdowns in clinical use.
Facilities with the impacted serial numbers should contact Siemens Medical Solutions USA, Inc. for firmware updates and instructions on correcting the issues.
The recalled product
- Product
- Artis icono floor with software VE20C-diagnostic imaging angiography system Model: 11327700
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Affected units
- 23
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 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.
See all 3 products in this recall →Related recalls
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