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.
What this means for you
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
- Hazard
- thermal-overload
- fire-hazard
- device-malfunction
Distribution
Distributed nationwide across the United States.
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