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Device product

Biograph mCT-S(64) 4R, MATERIAL NUMBER 10248672 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-2033-2016

April 22, 2016

Class II

Product summary

Firm
Siemens Medical Solutions USA Inc.
Event
Event 74192
Status
Terminated
Classification
Class II
Quantity
127 units
Official record key
device-enforcement:Z-2033-2016

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: 1013,11055,1005,1006,1004,1011,1003,1002,1008,1009,1010,11022,11028,1012,1016,1017,1019,11020,1007,11023,11024,11025,11026,11029,11030,11032,11033,11056,1018,11036,1014,11038,11039,11027,11049,11057,11040,11041,11042,11043,11031,11035,11044,11045,11034,11046,11047,11048,11037,11050,11051,11052,11053,11054,11058,11059,11060,11061,11062,11063,11064,11065,11067,11068,11069,11070,11071,11072,11074,11073,11075,11076,11066,11077,1001,11078,11079,11081,11083,11084,11082,11086,11087,11088,11080,11090,11091,11092,11094,11093,11096,21097,11095,21098,11089,21100,31110,21101,21102,21103,21099,21105,31106,11015,21104,31107,31108,31109,31111,31112,31113,31114,31124,31115,31117,31118,31119,31120,31121,90001,31122,31125,31126,1015,31116,31123,31127

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.

Field note

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