Agency classClass IIOur severity:High FDA (Devices)·Z-2359-2023·Announced 2023-08-16

Siemens ARTIS Icono Biplane Angiography Systems Thermal Cable Connector Defect

Siemens recalls ARTIS icono biplane angiography systems with defective cable connectors that may cause thermal overload, burning smell, and loss of imaging functionality during clinical 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 involving risk-of-harm medical equipment with no reported injuries or illnesses. The thermal overload and fire hazard are concrete but theoretical in terms of patient harm, placing this at Score 3 per the severity rubric.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling ARTIS icono biplane angiography systems (Material Number 11327600) worldwide. The recall affects 14 units with the following serial numbers: 180550, 180517, 180518, 180546, 180547, 180560, 180534, 180556, 180537, 180545, 180533, 180566, 180536, 180563. These are medical devices used for diagnostic and interventional imaging procedures.

The systems have a hardware defect in the cable connectors of the system generator. Under certain conditions—specifically during excessive fluoroscopy or image acquisitions—a thermal overload may occur in these connections. This can result in a burning smell coming from the generator cabinet and may cause the system to lose imaging functionality.

Loss of imaging functionality could require clinicians to cancel ongoing clinical treatment or switch to an alternative imaging system during procedures. The defect poses a potential safety concern in medical facilities performing diagnostic and interventional imaging.

Facilities with affected ARTIS icono biplane systems should contact Siemens Medical Solutions USA, Inc. for repair or replacement instructions. The FDA has classified this as a Class II recall. Users should verify the serial number of their system and follow the manufacturer's guidance.

The recalled product

Product: ARTIS icono biplane -Angiography systems developed for single and biplane diagnostic imaging and interventional procedures. Material Number: 11327600
Manufacturer: Siemens Medical Solutions USA, Inc
Category: Medical Device — Diagnostic and Interventional Imaging
Hazard: thermal-overload
fire
equipment-failure
Affected units: 14

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 →

Same manufacturer · Siemens Medical Solutions USA, Inc

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