The Recall Desk

FDA (Devices) recall action 76127

Siemens Medical Solutions USA Inc. recalled 11 products on 2017-01-18

The FDA (Devices) publishes a recall like this one as 11 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 11 pages.

Products
11
Announced
2017-01-18
Critical
0
Units
409

Why these products were recalled

Siemens Medical Solutions, Molecular Imaging has become aware, through our supplier that some laser cover windows may fall off.

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.

1–11 of 11

  • ModerateFDA (Devices)··2017-01-18

    Siemens Biograph mCT Flow 40-4R Laser Cover Window Recall

    Siemens Medical Solutions is recalling Biograph mCT Flow 40-4R scanners because laser cover windows may fall off.

    Product
    Biograph mCT Flow 40-4R, Material Number 10529159 The Siemens Biograph mCT and Biograph mCT Flow 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…
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  • ModerateFDA (Devices)··2017-01-18

    Siemens Biograph mCT Flow Edge-4R Scanner Recall for Laser Cover Windows

    Siemens Medical Solutions is recalling one Biograph mCT Flow Edge-4R scanner because laser cover windows may fall off.

    Product
    Biograph mCT Flow Edge-4R, Material Number 10528955 The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and…
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  • ModerateFDA (Devices)··2017-01-18

    Siemens Biograph mCT-X Scanner Recall Due to Falling Laser Cover Windows

    Siemens Medical Solutions is recalling Biograph mCT-X scanners because laser cover windows may fall off.

    Product
    Biograph mCT-X w/TrueV Upgrade, Material Number 10250745 The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and…
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  • ModerateFDA (Devices)··2017-01-18

    Siemens Biograph mCT Scanners Recalled for Falling Laser Cover Windows

    Siemens Medical Solutions is recalling 88 Biograph mCT scanners because laser cover windows may fall off.

    Product
    Biograph mCT S(40)-4R, Material Number 10248671 The Siemens Biograph mCT and Biograph mCT Flow 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…
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  • ModerateFDA (Devices)··2017-01-18

    Siemens Biograph mCT Scanners Recalled for Falling Laser Cover Windows

    Siemens is recalling 34 Biograph mCT scanners because laser cover windows may fall off, posing a potential hazard to users.

    Product
    Biograph mCT S(64)-3R, Material Number 10248669 The Siemens Biograph mCT and Biograph mCT Flow 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…
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  • ModerateFDA (Devices)··2017-01-18

    Siemens Biograph mCT PET/CT Scanner Laser Cover Window Recall

    Siemens Medical Solutions is recalling Biograph mCT PET/CT scanners because laser cover windows may fall off.

    Product
    Bio mCT-S(40) 3R->4R Upgrade, Material Number 10250743 The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and…
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  • ModerateFDA (Devices)··2017-01-18

    Siemens Biograph mCT PET/CT Scanners Recalled for Falling Laser Cover Windows

    Siemens Medical Solutions is recalling 102 Biograph mCT PET/CT scanners because laser cover windows may fall off.

    Product
    Biograph mCT S(64)-4R, Material Number 10248672 The Siemens Biograph mCT and Biograph mCT Flow 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…
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  • ModerateFDA (Devices)··2017-01-18

    Siemens Biograph mCT 20 Excel PET/CT Scanner Recall for Laser Cover Windows

    Siemens is recalling 51 Biograph mCT 20 Excel scanners because laser cover windows may fall off.

    Product
    BIOGRAPH mCT 20 Excel, Material Number 10507786 The Siemens Biograph mCT and Biograph mCT Flow 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…
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  • ModerateFDA (Devices)··2017-01-18

    Siemens Biograph mCT X-4R Laser Cover Window Recall

    Siemens is recalling 71 Biograph mCT X-4R scanners because laser cover windows may fall off.

    Product
    Biograph mCT X-4R, Material Number 10248670 The Siemens Biograph mCT and Biograph mCT Flow 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…
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  • ModerateFDA (Devices)··2017-01-18

    Siemens Biograph mCT PET/CT Scanner Laser Cover Window Recall

    Siemens is recalling 41 Biograph mCT PET/CT scanners because laser cover windows may fall off.

    Product
    Biograph mCT S(40)-3R, Material Number 10248668 The Siemens Biograph mCT and Biograph mCT Flow 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…
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  • ModerateFDA (Devices)··2017-01-18

    Siemens Biograph mCT X-3R Scanners Recalled for Falling Laser Cover Windows

    Siemens Medical Solutions is recalling 18 Biograph mCT X-3R scanners because laser cover windows may fall off.

    Product
    Biograph mCT X-3R, Material Number 10248673 The Siemens Biograph mCT and Biograph mCT Flow 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…
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