Siemens Artis icono Angiography Systems: Risk of Electric Shock from Grounding Failure
Siemens is recalling 51 Artis icono biplane angiography systems due to a potential grounding failure that could allow electric shock if someone contacts metallic parts during 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 a Class II medical device recall involving potential electric shock, a serious injury hazard. No hospitalizations, injuries, or deaths have been reported in the source material. The hazard is contingent on multiple simultaneous conditions (interrupted grounding plus additional fault), fitting the criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 51 Artis icono biplane angiography systems due to a potential electrical safety hazard. These systems are used for single and biplane diagnostic imaging and interventional procedures.
The recalled units have a vulnerability in the protective grounding system. If the protective earth becomes interrupted and an additional electrical fault occurs, the system's fault current detection may not function properly, potentially resulting in an electric shock if a person comes into contact with metallic parts of the device.
The affected systems were distributed nationwide in the United States. The FDA classified this as a Class II recall.
The recalled product
- Product
- Artis icono biplane -angiography systems developed for single and biplane diagnostic imaging and interventional procedures SMN: 11327600
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Hazard
- electric-shock
- grounding-failure
- fault-detection-failure
Distribution
Distributed nationwide across the United States.
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