The Recall Desk

FDA (Devices) recall action 74192

Siemens Medical Solutions USA Inc. recalled 33 products on 2016-06-29

The FDA (Devices) publishes a recall like this one as 33 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 33 pages.

Products
33
Announced
2016-06-29
Critical
0
Units
1,075

Why these products were recalled

Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.

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.

1–25 of 33

  • ModerateFDA (Devices)··2016-06-29

    Siemens Biograph mCT-S PET/CT Scanners Recalled for Calibration Error

    Siemens Medical Solutions is recalling 100 Biograph mCT-S PET/CT scanners because using non-Siemens phantoms for calibration may result in unexpected SUV values.

    Product
    Biograph mCT-S(40) 4R, MATERIAL NUMBER 10248671 The Siemens Biograph TruePoint 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.
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  • ModerateFDA (Devices)··2016-06-29

    Siemens Biograph PET/CT Scanners Recalled for Calibration Error Risk

    Siemens is recalling 46 Biograph 40 TruePoint PET/CT scanners due to a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.

    Product
    BIOGRAPH 40 TruePoint w/TrueV, Material Number 10097304 The Siemens Biograph TruePoint 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)··2016-06-29

    Siemens Biograph mCT-X 3R PET/CT Scanner Recall for Calibration Error

    Siemens is recalling 22 Biograph mCT-X 3R PET/CT scanners because using non-Siemens phantoms for calibration may result in unexpected SUV values.

    Product
    Biograph mCT-X 3R, MATERIAL NUMBER 10248673 The Siemens Biograph TruePoint 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.
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  • ModerateFDA (Devices)··2016-06-29

    Siemens Biograph 16 TruePoint TV Recall for Calibration Error

    Siemens is recalling 36 Biograph 16 TruePoint TV scanners because using non-Siemens phantoms for calibration may result in unexpected SUV values.

    Product
    Biograph 16 TruePoint TV, Material Number 10249556 The Siemens Biograph TruePoint 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.
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  • ModerateFDA (Devices)··2016-06-29

    Siemens Biograph 64 PET/CT Scanner Recall for Calibration Error

    Siemens is recalling 15 Biograph 64 PET/CT scanners because using non-Siemens phantoms for calibration may result in unexpected SUV values.

    Product
    BIOGRAPH 64 - 3 Ring, Material Number 08727450 The Siemens Biograph TruePoint 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.
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  • ModerateFDA (Devices)··2016-06-29

    Siemens Biograph 16 TruePoint PET/CT Scanners Recalled for Calibration Error

    Siemens is recalling 63 Biograph 16 TruePoint PET/CT scanners because using non-Siemens phantoms for calibration may result in unexpected SUV values.

    Product
    Biograph 16 TruePoint, MATERIAL NUMBER 10249555 The Siemens Biograph TruePoint 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.
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  • ModerateFDA (Devices)··2016-06-29

    Siemens Biograph mCT-S PET/CT Scanner Recall for Calibration Error

    Siemens is recalling 47 Biograph mCT-S PET/CT scanners because using non-Siemens phantoms for calibration may result in unexpected SUV values.

    Product
    Biograph mCT-S(40) 3R, MATERIAL NUMBER 10248668 The Siemens Biograph TruePoint 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.
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  • ModerateFDA (Devices)··2016-06-29

    Siemens Biograph TruePoint PET/CT Scanner Recall for Calibration Error

    Siemens Medical Solutions is recalling four Biograph TruePoint PET/CT scanners due to a risk of unexpected SUV values when using non-Siemens phantoms for calibration.

    Product
    SYS IVK, Bio mCT-S(40) 3R->4R Upgrade, MATERIAL NUMBER 10250743 The Siemens Biograph TruePoint 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)··2016-06-29

    Siemens Biograph mCT-S PET/CT scanners recalled for calibration error risk

    Siemens is recalling 127 Biograph mCT-S PET/CT scanners because using non-Siemens phantoms for calibration may result in unexpected SUV values.

    Product
    Biograph mCT-S(64) 4R, MATERIAL NUMBER 10248672 The Siemens Biograph TruePoint 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.
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  • ModerateFDA (Devices)··2016-06-29

    Siemens Biograph TruePoint PET/CT Scanner Recall for Calibration Error

    Siemens is recalling four Biograph TruePoint PET/CT scanners due to a potential for unexpected SUV values when non-Siemens phantoms are used for calibration.

    Product
    BIOGRAPH Sys 40-3R to 40-4R, MATERIAL NUMBER 10246388 The Siemens Biograph TruePoint 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)··2016-06-29

    Siemens Biograph PET/CT Scanners Recalled for Calibration Error Risk

    Siemens is recalling 49 Biograph PET/CT scanners because using non-Siemens phantoms for calibration may result in unexpected SUV values.

    Product
    BIOGRAPH 64-4R TruePoint w/TrueV, MATERIAL NUMBER 10097302 The Siemens Biograph TruePoint 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)··2016-06-29

    Siemens Biograph TruePoint PET/CT Scanners Recalled for Calibration Error

    Siemens is recalling five Biograph TruePoint PET/CT scanners because using a non-Siemens phantom for calibration may result in unexpected SUV values.

    Product
    BIOGRAPH mCT S(20)-4R, MATERIAL NUMBER 10534160 The Siemens Biograph TruePoint 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.
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  • ModerateFDA (Devices)··2016-06-29

    Siemens Biograph TruePoint PET/CT Scanner Recall for Calibration Error

    Siemens is recalling two Biograph TruePoint PET/CT scanners due to a potential for unexpected SUV values when using non-Siemens phantoms for calibration.

    Product
    SYS IVK, Bio mCT-X 3R->4R Upgrade, MATERIAL NUMBER 10250745 The Siemens Biograph TruePoint 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)··2016-06-29

    Siemens Biograph mCT Flow 40-4R Recalled for Calibration Error Risk

    Siemens Medical Solutions is recalling nine Biograph mCT Flow 40-4R scanners due to a potential for unexpected SUV values if non-Siemens phantoms are used for calibration.

    Product
    BIOGRAPH mCT Flow 40-4R, MATERIAL NUMBER 10529159 The Siemens Biograph TruePoint 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.
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  • ModerateFDA (Devices)··2016-06-29

    Siemens Biograph mCT S(20) - 3R PET/CT Scanner Recall

    Siemens is recalling 143 Biograph mCT S(20) - 3R scanners due to a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.

    Product
    BIOGRAPH mCT S(20) - 3R, MATERIAL NUMBER 10507786 The Siemens Biograph TruePoint 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.
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  • ModerateFDA (Devices)··2016-06-29

    Siemens Biograph PET/CT Scanner Recall for Calibration Error Risk

    Siemens is recalling Biograph 6 TP scanners due to a potential for unexpected SUV values when using non-Siemens phantoms for calibration.

    Product
    Biograph 6 TP 3R to 4R Upgrade, Material Number 10246387 The Siemens Biograph TruePoint 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)··2016-06-29

    Siemens Biograph mCT Flow Edge-3R Recalled for Calibration Error

    Siemens is recalling two Biograph mCT Flow Edge-3R scanners due to a potential for unexpected SUV values when using non-Siemens phantoms for calibration.

    Product
    BIOGRAPH mCT Flow Edge-3R, MATERIAL NUMBER 10528954 The Siemens Biograph TruePoint 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.
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  • ModerateFDA (Devices)··2016-06-29

    Siemens Biograph mCT-S PET/CT Scanners Recalled for Calibration Error

    Siemens is recalling 51 Biograph mCT-S PET/CT scanners because using non-Siemens phantoms for calibration may result in unexpected SUV values.

    Product
    Biograph mCT-S(64) 3R, MATERIAL NUMBER 10248669 The Siemens Biograph TruePoint 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.
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  • ModerateFDA (Devices)··2016-06-29

    Siemens Biograph TruePoint CT/PET Scanner Upgrade Recalled for Calibration Error

    Siemens is recalling a Biograph TruePoint upgrade kit because using a non-Siemens phantom for calibration may result in unexpected SUV values.

    Product
    BIOGRAPH 40-3R to 64-3R Upgrade, Material Number 10246390 The Siemens Biograph TruePoint 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)··2016-06-29

    Siemens Biograph 6 TruePoint Scanners Recalled for Calibration Error Risk

    Siemens Medical Solutions is recalling 102 Biograph 6 TruePoint scanners due to a potential for unexpected SUV values when non-Siemens phantoms are used for calibration.

    Product
    BIOGRAPH 6 TruePoint, Material Number 10097289 The Siemens Biograph TruePoint 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.
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  • ModerateFDA (Devices)··2016-06-29

    Siemens Biograph PET/CT Scanners Recalled for Calibration Error Risk

    Siemens is recalling Biograph 6-4R TruePoint PET/CT scanners because using non-Siemens phantoms for calibration may result in unexpected SUV values.

    Product
    BIOGRAPH 6-4R TruePoint w/TrueV, MATERIAL NUMBER 10097290 The Siemens Biograph TruePoint 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)··2016-06-29

    Siemens Biograph PET/CT Scanners Recalled for Calibration Error Risk

    Siemens is recalling nine Biograph mCT Flow 20-3R scanners because using non-Siemens phantoms for calibration may result in unexpected SUV values.

    Product
    BIOGRAPH mCT Flow 20-3R, MATERIAL NUMBER 10528956 The Siemens Biograph TruePoint 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.
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  • ModerateFDA (Devices)··2016-06-29

    Siemens Biograph PET/CT Scanners Recalled for Calibration Error Risk

    Siemens is recalling 12 Biograph mCT Flow 64-3R scanners because using non-Siemens phantoms for calibration may result in unexpected SUV values.

    Product
    BIOGRAPH mCT Flow 64-3R, MATERIAL NUMBER 10529160 The Siemens Biograph TruePoint 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.
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  • ModerateFDA (Devices)··2016-06-29

    Siemens Biograph PET/CT Scanners Recalled for Calibration Error Risk

    Siemens is recalling two Biograph PET/CT scanners due to a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.

    Product
    BIOGRAPH SYS 64-3R to 64-4R, MATERIAL NUMBER 10246389 The Siemens Biograph TruePoint 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.
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  • ModerateFDA (Devices)··2016-06-29

    Siemens Biograph PET/CT Scanners Recalled for Calibration Error Risk

    Siemens is recalling 28 Biograph mCT Flow 20-4R PET/CT scanners because using non-Siemens phantoms for calibration may result in unexpected SUV values.

    Product
    BIOGRAPH mCT Flow 20-4R, MATERIAL NUMBER 10528958 The Siemens Biograph TruePoint 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.
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