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Recall Observatory FDA recall evidence

Device 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.

Z-2030-2016

April 22, 2016

Class II

Product summary

Firm
Siemens Medical Solutions USA Inc.
Event
Event 74192
Status
Terminated
Classification
Class II
Quantity
47 units
Official record key
device-enforcement:Z-2030-2016

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: 1002,1004,1006,1007,1005,1010,1013,1016,1017,11018,11019,11031,1012,11020,1014,11026,11022, 1015,11024,11025,11023,11027,11028,11030,11032,11038,11033,11034,11036,11039,11037,11040, 11041,11044,11042,21045,21048,31047,31049,11029,1008,1009,1011,11021,11033,11035,31046

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.