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.
Check against the official notice below — it lists the full affected range.
Siemens Medical Solutions has recalled 83 units of the Biograph mCT-X 4R system, a combined X-Ray CT and PET imaging device, due to a potential for unexpected SUV (Standardized Uptake Value) readings when a non-Siemens phantom is used for calibration. The affected units have been distributed worldwide and throughout the United States, with specific serial numbers identified in the recall notice.
The source document does not specify a remedy or recommended course of action for consumers or healthcare facilities with affected units.
Written by software from the official notice below. Not reviewed by a lawyer.
Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.
Reason for recall: Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration. Distribution: Worldwide Distribution - US Nationwide Quantity: 83 units Lot/code info: 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
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.