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Recall Observatory FDA recall evidence

Device 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.

Z-2013-2016

April 22, 2016

Class II

Product summary

Firm
Siemens Medical Solutions USA Inc.
Event
Event 74192
Status
Terminated
Classification
Class II
Quantity
15 units
Official record key
device-enforcement:Z-2013-2016

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: 1001,1002,1003,1004,1007,1010,1012,1013,1014,1015,1016,1017,1018,1019,1022

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.