Siemens Artis Angiography Systems Software Error May Delay Clinical Treatment
Certain Siemens Artis angiography systems with software version VD12 may fail to start up properly due to a software error, potentially delaying clinical imaging procedures. The issue affects specific units identified by serial number.
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 an FDA Class II recall involving a medical device with a software error that can delay clinical treatment. No hospitalizations, injuries, or deaths are reported in the source material. The recall meets the High severity criterion as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling specific models of Artis angiography systems with software version VD12, including Artis zee, Artis Q, and Artis Q.zen models in floor, ceiling, and biplane configurations. These diagnostic imaging systems are used for angiography procedures in clinical settings.
The Image Acquisition System (IAS) software contains an error that may cause the system to fail sporadically during startup or restart, potentially delaying clinical treatment. The affected units are identified by specific serial numbers and have been distributed to clinical facilities across the United States.
Approximately 70 affected units have been identified in the U.S. distributed across multiple states. Clinical facilities using these systems should contact Siemens Medical Solutions USA, Inc. to obtain corrective software updates or other remedial actions.
The recalled product
- Product
- Artis Models with SW version VD12 listed below: Artis zee floor 10094135 Artis zee ceiling 10094137 Artis zee MP 10094139 Artis Q floor 10848280 Artis Q ceiling 10848281 Artis Q biplane 10848282 Artis Q.zen floor 10848353 Artis Q.zen ceiling 10848354…
- Manufacturer
- Siemens Medical Solutions USA, Inc
Distribution
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