Recall Z-2019-2016— Siemens Medical Solutions USA Inc.

Name: FDA recall Z-2019-2016
Creator: U.S. Food and Drug Administration
Published: 2016-04-22

Class II · Terminated

Class II FDA medical device recall by Siemens Medical Solutions USA Inc., initiated 2016-04-22, terminated 2017-05-08. It names one FDA 510(k) clearance: K141971. Product: BIOGRAPH SYS 64-3R to 64-4R, MATERIAL NUMBER 10246389 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.. 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..

Recalling firm: Siemens Medical Solutions USA Inc.
Classification: Class II
Status: Terminated
Initiated: 2016-04-22
Terminated: 2017-05-08
Firm location: Knoxville, TN, United States

510(k) clearances named in this recall

1 on FDA's record

K141971 — BIOGRAPH TRUE PET/CT FAMILY SOFTWARESiemens Medical Solutions USA, Inc.·cleared 2014-09-12

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

BIOGRAPH SYS 64-3R to 64-4R, MATERIAL NUMBER 10246389 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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.