Agency classClass IIOur severity:High FDA (Devices)·Z-1245-2022·Announced 2022-06-15

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.

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 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
Category: Medical Device — Diagnostic Imaging
Hazard: electric-shock
grounding-failure
fault-detection-failure
Affected units: 51

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 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 2 products in this recall →

Same manufacturer · Siemens Medical Solutions USA, Inc

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