Skip to content
Recall Observatory FDA recall evidence

Device product

Biograph mCT-X 4R, MATERIAL NUMBER 10248670 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-2005-2016

April 22, 2016

Class II

Product summary

Firm
Siemens Medical Solutions USA Inc.
Event
Event 74192
Status
Terminated
Classification
Class II
Quantity
83 units
Official record key
device-enforcement:Z-2005-2016

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: 1002,1003,1001,1004,1005,1006,1008,1009,1010,1007,1011,11013,11014,11015,11016,11017,11018,11020,11012,11019,11021,11022,11023,11026,11025,11024,11027,11044,11029,11028,11030,11031,11032,11033,11034,11037,11036,11038,11040,11042,11039,11035,11045,11046,11041,11047,11048, 11049,11050,11051,11052,11054,11055,11056,11043,11058,11059,11057,11061,11060,11062,11063,11064,11065,11066,11067,11068,11069,11070,21071,21073,21072,21074,31075,31076,31077,31083,31079,31080,31081,31082,31078,40001091760

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.