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Recall Observatory FDA recall evidence

Device 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 information.

Z-2016-2016

April 22, 2016

Class II

Product summary

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

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: 1001,1004,1015,1020,1024,1035,1042,44889,44977,45502,45509,45516,45518,45520,45522,45525,45527,45528,45532,45533,45539,45544,45547,45549,45554,45556,45560,45564,45574,45586,45587,45590,45600,45612,45615,45656,45660

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.