Agency classClass IIOur severity:High FDA (Devices)·Z-2360-2023·Announced 2023-08-16

Angiography systems recalled due to thermal overload in cable connectors

Siemens ARTIS icono floor angiography systems may experience thermal overload in cable connectors during fluoroscopy, causing burning smell and loss of imaging capability. The recall affects 7 units worldwide.

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 risk-of-harm product with no reported illnesses or injuries, fitting the FDA Class II criteria without hospitalization reports. The thermal overload hazard in a critical clinical imaging device could disrupt patient care, justifying a High severity classification.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling the ARTIS icono floor angiography system (Material Number 11327700), used for single and biplane diagnostic imaging and interventional procedures. A total of 7 units have been affected.

The recall is due to a hardware defect in the cable connectors of the system generator. During excessive fluoroscopy or acquisition operations, the cable connectors may experience thermal overload. This can produce a burning smell detectable from the generator cabinet and may cause the system to lose imaging functionality for the affected plane, necessitating cancellation of clinical treatment or transfer to an alternative system.

The affected systems have been distributed worldwide, including throughout the United States and to numerous international locations. Facilities operating these systems should contact Siemens Medical Solutions USA, Inc. immediately if they suspect any related issues. If a burning smell is detected or if imaging functionality is unexpectedly lost, the affected system should be taken out of service immediately.

This is an FDA Class II medical device recall (FDA Recall Number Z-2360-2023). Affected units can be identified by UDI-DI 4056869149325 and serial numbers 170561, 170549, 170559, 170546, 170552, 170571, and 170570.

The recalled product

Product: ARTIS icono floor-Angiography systems developed for single and biplane diagnostic imaging and interventional procedures. Material Number: 11327700
Manufacturer: Siemens Medical Solutions USA, Inc
Category: Medical Device — Diagnostic Imaging Equipment
Hazard: thermal-overload
burning-smell
equipment-failure
Affected units: 7

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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Same hazard · thermal overload