Agency classClass IIOur severity:High FDA (Devices)·Z-2361-2023·Announced 2023-08-16

Siemens ARTIS Angiography Systems: Thermal Overload Risk in Cable Connectors

Siemens has recalled 10 ARTIS angiography systems due to thermal overload hazard in cable connectors. The issue may cause burning smell and loss of imaging functionality, potentially requiring treatment cancellation or system replacement.

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 FDA Class II recall addresses a potential thermal overload hazard in medical imaging equipment that could result in burning smell and loss of device functionality. No illnesses or injuries have been reported. The primary concern is operational disruption to clinical procedures and potential thermal hazard, fitting the rubric criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Siemens Medical Solutions USA, Inc. has recalled 10 ARTIS pheno-Angiography systems (Material Number 10849000) due to a hardware issue in the cable connectors of the system generator. A thermal overload in the cable connections may occur when performing excessive fluoroscopy or image acquisition operations.

When the thermal overload occurs, a burning smell may be detectable from the generator cabinet. The system may lose imaging functionality of the affected plane, requiring the clinical team to cancel the procedure or continue treatment on an alternative imaging system.

The recall affects 10 units with the following serial numbers: 164840, 164851, 164854, 164853, 164855, 164856, 164833, 164836, 164845, and 164850. These systems have been distributed worldwide, including throughout the United States and to 43 additional countries.

Healthcare facilities operating these devices should contact Siemens Medical Solutions USA, Inc. to address the cable connector issue.

The recalled product

Product: ARTIS pheno-Angiography systems developed for single and biplane diagnostic imaging and interventional procedures. Material Number: 10849000
Manufacturer: Siemens Medical Solutions USA, Inc
Category: Medical Device — Diagnostic Imaging Equipment
Hazard: thermal-overload
fire-hazard
device-malfunction
Affected units: 10

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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