Recall Z-1425-2017— Siemens Medical Solutions USA Inc.

Name: FDA recall Z-1425-2017
Creator: U.S. Food and Drug Administration
Published: 2017-02-20

Class II · Terminated

Class II FDA medical device recall by Siemens Medical Solutions USA Inc., initiated 2017-02-20, terminated 2017-09-17. It names one FDA 510(k) clearance: K141971. Product: Biograph 16 TruePoint TrueV - 4R, Material Number 10249556 The Biograph Mobile PET/CTs are intended to be utilized by appropriately trained health care professionals to: ¿ Image and measure the distribution of injected positron emitting radiopharmaceuticals in humans for the purpose of determining various metabolic (molecular) and physiologic functions within the human body; and ¿ Produce cross-sectional images of the body by computer reconstruction of XRay transmission data from either the same axial plan taken at different angles or spiral planes taken at different angles.. Reason: The mobile-specific instructions was not shipped to a limited population of Biograph Mobile systems..

Recalling firm: Siemens Medical Solutions USA Inc.
Classification: Class II
Status: Terminated
Initiated: 2017-02-20
Terminated: 2017-09-17
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 16 TruePoint TrueV - 4R, Material Number 10249556 The Biograph Mobile PET/CTs are intended to be utilized by appropriately trained health care professionals to: ¿ Image and measure the distribution of injected positron emitting radiopharmaceuticals in humans for the purpose of determining various metabolic (molecular) and physiologic functions within the human body; and ¿ Produce cross-sectional images of the body by computer reconstruction of XRay transmission data from either the same axial plan taken at different angles or spiral planes taken at different angles.

Reason for recall

The mobile-specific instructions was not shipped to a limited population of Biograph Mobile systems.

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