The Recall Desk

FDA (Devices) recall action 86166

Siemens Medical Solutions USA, Inc recalled 2 products on 2020-09-02

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
2020-09-02
Critical
0
Units
658

Why these products were recalled

Siemens has become aware of a hardware error which affects Cios Spin and Cios Alpha systems after the previous repair of the X-ray Generator with an integrated Energy Storage Unit (ESU).

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)··2020-09-02

    Siemens Recalls Cios Spin and Cios Alpha X-Ray Systems Due to Hardware Error

    Siemens is recalling 329 Cios Spin and Cios Alpha mobile X-ray systems due to a hardware error affecting the X-ray Generator with an integrated Energy Storage Unit.

    Product
    Cios Spin, Image-Intensified Fluoroscopic X-Ray System 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
    15 states
  • HighFDA (Devices)··2020-09-02

    Siemens Recalls Cios Alpha and Spin X-Ray Systems for Hardware Error

    Siemens is recalling 329 Cios Alpha and Cios Spin mobile X-ray systems due to a hardware error affecting the X-ray generator after a previous repair.

    Product
    Cios Alpha, Image-Intensified Fluoroscopic X-Ray System 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
    15 states