The Recall Desk

FDA (Devices) recall action 69897

Siemens Medical Solutions USA Inc. recalled 5 products on 2014-12-24

The FDA (Devices) publishes a recall like this one as 5 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 5 pages.

Products
5
Announced
2014-12-24
Critical
0
Units
29

Why these products were recalled

Possibility for system display freeze during CT interventional procedures.

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

1–5 of 5

  • HighFDA (Devices)··2014-12-24

    Siemens Biograph mCT Flow 40-4R Recalled for Display Freeze Risk

    Siemens Medical Solutions is recalling one Biograph mCT Flow 40-4R scanner due to a potential display freeze during CT interventional procedures.

    Product
    Biograph mCT Flow 40-4R, System Material Number 10529159. The Siemens Biograph mCT systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
    Category
    Distribution
    2 states
  • HighFDA (Devices)··2014-12-24

    Siemens Biograph mCT Flow Edge-4R Recalled for Display Freeze Risk

    Siemens Medical Solutions USA Inc. is recalling four Biograph mCT Flow Edge-4R scanners due to a potential system display freeze during CT interventional procedures.

    Product
    Biograph mCT Flow Edge-4R, System Material Number 10528955. The Siemens Biograph mCT systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic…
    Category
    Distribution
    2 states
  • HighFDA (Devices)··2014-12-24

    Siemens Biograph mCT Scanners Recalled for Potential Display Freeze

    Siemens Medical Solutions is recalling eight Biograph mCT S(64)-4R scanners due to a risk of system display freeze during CT interventional procedures.

    Product
    Biograph mCT S(64)-4R, System Material Number 10248672. The Siemens Biograph mCT systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
    Category
    Distribution
    2 states
  • HighFDA (Devices)··2014-12-24

    Siemens Biograph mCT X-4R Recalled for Potential Display Freeze During Procedures

    Siemens Medical Solutions is recalling eight Biograph mCT X-4R scanners due to a possibility of system display freeze during CT interventional procedures.

    Product
    Biograph mCT X-4R, System Material Number 10248670. The Siemens Biograph mCT systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
    Category
    Distribution
    2 states
  • HighFDA (Devices)··2014-12-24

    Siemens Biograph mCT S(40)-4R Recalled for Display Freeze Risk

    Siemens Medical Solutions is recalling eight Biograph mCT S(40)-4R scanners due to a potential system display freeze during CT interventional procedures.

    Product
    Biograph mCT S(40)-4R, System Material Number 10248671. The Siemens Biograph mCT systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
    Category
    Distribution
    2 states