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.

26–33 of 33

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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0 states
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 infor
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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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0 states
HighFDA (Devices)··2016-06-29
Siemens Biograph mCT-X 4R PET/CT Scanners Recalled for Calibration Error
Siemens is recalling 83 Biograph mCT-X 4R scanners because using non-Siemens phantoms for calibration may result in unexpected SUV values.
Product
Biograph mCT-X 4R, MATERIAL NUMBER 10248670 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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0 states
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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0 states
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.
Category
Distribution
0 states
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.
Category
Distribution
0 states
ModerateFDA (Devices)··2016-06-29
Siemens Biograph 40 TruePoint PET/CT Scanner Recall for Calibration Error
Siemens is recalling 48 Biograph 40 TruePoint PET/CT scanners because using non-Siemens phantoms for calibration may result in unexpected SUV values.
Product
BIOGRAPH 40 TruePoint, Material Number 10097303 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.
Category
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0 states