The Recall Desk

FDA (Devices) recall action 85553

Siemens Medical Solutions USA, Inc recalled 3 products on 2020-05-20

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
2020-05-20
Critical
0
Units
66

Why these products were recalled

Main cable can be plugged or unplugged from the X10 connector which is part of the main unit (c-arm) at any time during clinical session. If the system displays the error message Err 16305 / 80, the unplugging of the main cable can cause an unsafe electrical voltage (125 V DC) at the X10 connector and result in an electrical shock if the user or other persons touch the contact pins of the X10 connector. These contact pins are accessible when the main cable is unplugged from 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.

1–3 of 3

  • HighFDA (Devices)··2020-05-20

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

    Siemens is recalling 16 Cios Alpha mobile X-ray systems because unplugging the main cable during a clinical session can expose users to unsafe electrical voltage and shock.

    Product
    Siemens Cios Alpha VA30-mobile X-Ray system, Material # 11105200 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
    0 states
  • SevereFDA (Devices)··2020-05-20

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

    Siemens is recalling four Cios Alpha mobile X-ray systems because unplugging the main cable during a clinical session can expose users to unsafe electrical voltage.

    Product
    Siemens Cios Alpha VA20-mobile X-Ray system Material # 10308191 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
    0 states
  • HighFDA (Devices)··2020-05-20

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

    Siemens is recalling 46 Cios Spin mobile X-ray systems because unplugging the main cable during a clinical session can expose users to unsafe electrical voltage.

    Product
    Siemens Cios Spin VA30-mobile X-Ray system, Material # 10308194 - Product Usage: 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
    0 states