Siemens Medical Solutions USA, Inc: if the protective earth is interrupted and an additional fault leads to a fault current, the detection of the fault current may not be ensured may cause an electric shock if a person is in contact with metallic parts of the Carm

Agency Publication Date: June 7, 2022

Affected Products

Product: Artis icono biplane -angiography systems developed for single and biplane diagnostic imaging and interventional procedures SMN: 11327600

UDI-DI: 04056869063317 Serial Number: 180062 180054 180019 180065 180056 180057 180041 180317 180034 180072 180060 180070 180048 180083 180315 180080 180301 180305 180067 180330 180040 180333 180029 180336 180316 180084 180334 180018 180046 180047 180335 180085 180035 180081 180331 180021 180321 180309 180323 180329 180043 180049 180077 180086 180053 180055 180015 180014 180066 180082 180037

Product: Artis icono floor-angiography systems developed for single and biplane diagnostic imaging and interventional procedures SMN: 11327700

UDI-DI: 04056869149325 Serial Number: 170026 170305 170307 170309 170310 170023 170304 170025 170051 170312 170027 170303 170053

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 90184

Status: Active

Manufacturer: Siemens Medical Solutions USA, Inc

Manufactured In: United States

Units Affected: 2 products (51 units; 13 units)

Were You Affected by This Recall?

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

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Affected Products

Product: Artis icono biplane -angiography systems developed for single and biplane diagnostic imaging and interventional procedures SMN: 11327600

Product: Artis icono floor-angiography systems developed for single and biplane diagnostic imaging and interventional procedures SMN: 11327700

UDI-DI: 04056869149325 Serial Number: 170026 170305 170307 170309 170310 170023 170304 170025 170051 170312 170027 170303 170053

Siemens Medical Solutions USA, Inc: if the protective earth is interrupted and an additional fault leads to a fault current, the detection of the fault current may not be ensured may cause an electric shock if a person is in contact with metallic parts of the Carm

Affected Products

Additional Information

Were You Affected by This Recall?

Siemens Medical Solutions USA, Inc: if the protective earth is interrupted and an additional fault leads to a fault current, the detection of the fault current may not be ensured may cause an electric shock if a person is in contact with metallic parts of the Carm

Affected Products

Additional Information

Were You Affected by This Recall?

Siemens Medical Solutions USA, Inc: if the protective earth is interrupted and an additional fault leads to a fault current, the detection of the fault current may not be ensured may cause an electric shock if a person is in contact with metallic parts of the Carm

Siemens Medical Solutions USA, Inc: if the protective earth is interrupted and an additional fault leads to a fault current, the detection of the fault current may not be ensured may cause an electric shock if a person is in contact with metallic parts of the Carm