The Recall Desk

FDA (Devices) recall action 85572

Siemens Medical Solutions USA, Inc recalled 2 products on 2020-06-03

The FDA (Devices) publishes a recall like this one as 2 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 2 pages.

Products
2
Announced
2020-06-03
Critical
0
Units
78

Why these products were recalled

The unplugging of the main cable on the monitor trolley from the X10 connector can cause an unsafe electrical voltage (up to 67,6 V DC) at the X10 connector. This can result in an electrical shock if the user or other persons touch the contact pins of the X10 connector.

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.

States named across these recalls

1–2 of 2

  • HighFDA (Devices)··2020-06-03

    Siemens Cios Alpha X-Ray System Recalled for Electrical Shock Risk

    Siemens is recalling 58 Cios Alpha X-Ray systems because unplugging the monitor cable can expose users to unsafe electrical voltage, posing a shock hazard.

    Product
    Cios Alpha Image-Intensified Fluoroscopic X-Ray System, Model Numbers VA20-10308191 and VA30-10308194 The Cios Alpha and Cios Spin are a mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications.
    Category
    Distribution
    24 states
  • SevereFDA (Devices)··2020-06-03

    Siemens Cios Spin X-Ray System Recalled for Electrical Shock Risk

    Siemens is recalling 20 Cios Spin X-Ray systems because unplugging the monitor cable can create unsafe voltage, posing an electrical shock hazard.

    Product
    Cios Spin Image-Intensified Fluoroscopic X-Ray System, Model Numbers VA30-10308194
    Category
    Distribution
    24 states