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Recall Observatory FDA recall evidence

Device 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.

Z-2037-2016

April 22, 2016

Class II

Product summary

Firm
Siemens Medical Solutions USA Inc.
Event
Event 74192
Status
Terminated
Classification
Class II
Quantity
63 units
Official record key
device-enforcement:Z-2037-2016

Official wording

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

Code information: Serial Numbers: 72402,72404,72407,72414,72419,72420,72421,72427,72429,72431,72433,72434,72435,72436,72437,72440,72441,72443,72444,72445,72448,72450,72453,72455,72457,72459,72460,72461,72464,72465,72466,72468,72471,72472,72475,72476,72477,72481,72486,72487,72489,72491,72492,72494,72495, 72496,72497,72499,72501,72502,72503,72504,72505,72512,72515,72521,72523,72526,72528,72530,72531,72535,72537

Distribution pattern: Worldwide Distribution - US Nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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