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Recall Observatory FDA recall evidence

Device product

Biograph mCT-S(64) 3R, MATERIAL NUMBER 10248669 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-2032-2016

April 22, 2016

Class II

Product summary

Firm
Siemens Medical Solutions USA Inc.
Event
Event 74192
Status
Terminated
Classification
Class II
Quantity
51 units
Official record key
device-enforcement:Z-2032-2016

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: 1003,1004,1005,1006,1007,11009,11010,11011,11012,11013,11014,11023,11015,11016,11017,11018,11019,11020,11021,11022,11025,11028,11029,11027,31042,11024,11026,11033,11032,21034,31037,31040,21035,11031,11030,21036,31038,31039,31046,31041,31043,31045,31047,31048,31044,31049, 31050,31051,31054,1008,31053

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.