FDAClass IIJune 29, 2016

BIOGRAPH 40 TruePoint recall

BIOGRAPH 40 TruePoint, Material Number 10097303 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron…

Why was BIOGRAPH 40 TruePoint recalled?

Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Serial Numbers: 1003,1004,1005,1006,1009,1011,1012,1013,1014,1015,1016,1017,1018,1019,1020,1022,1023,1024,1028,1029,1030,1031,1032,1033,1034,1035,1036,1037,1039,1041,1042,1043,1044,1045,1046,1047,1049,1050,1051,1052,1053,1054,11055,11056,11059,11060,11061,11063

Product
BIOGRAPH 40 TruePoint, Material Number 10097303 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron…
Recalling firm
Siemens Medical Solutions USA Inc.
Quantity
48 units
Distribution
Worldwide Distribution - US Nationwide
Recall date
June 29, 2016
Classification
Class II
Status
Terminated
Agency
FDA (device)
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