The Recall Desk

FDA (Devices) recall action 92653

Siemens Medical Solutions USA, Inc recalled 3 products on 2023-08-16

The FDA (Devices) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.

Products
3
Announced
2023-08-16
Critical
0
Units
31

Why these products were recalled

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/acquisitions, a burning smell may be detectable coming from the generator cabinet and the system may lose the imaging functionality of the corresponding plane and result in a situation where it is necessary to cancel clinical treatment or to continue treatment on an alternative system

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–3 of 3

  • HighFDA (Devices)··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.

    Product
    ARTIS pheno-Angiography systems developed for single and biplane diagnostic imaging and interventional procedures. Material Number: 10849000
    Category
    Distribution
    0 states
  • HighFDA (Devices)··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.

    Product
    ARTIS icono floor-Angiography systems developed for single and biplane diagnostic imaging and interventional procedures. Material Number: 11327700
    Category
    Distribution
    0 states
  • HighFDA (Devices)··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.

    Product
    ARTIS icono biplane -Angiography systems developed for single and biplane diagnostic imaging and interventional procedures. Material Number: 11327600
    Category
    Distribution
    0 states