Recall Z-0177-2019— Siemens Medical Solutions USA, Inc.

Name: FDA recall Z-0177-2019
Creator: U.S. Food and Drug Administration
Published: 2018-09-28

Class II · Terminated

Class II FDA medical device recall by Siemens Medical Solutions USA, Inc., initiated 2018-09-28, terminated 2021-02-11. It names one FDA 510(k) clearance: K170904. Product: Biograph Horizon a) 3R, Material Number 10532746 b) 4R, Material Number 10532748 The Siemens Biograph Horizon and Biograph mCT 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: The terminals on the plug may become loose and overheat..

Recalling firm: Siemens Medical Solutions USA, Inc.
Classification: Class II
Status: Terminated
Initiated: 2018-09-28
Terminated: 2021-02-11
Firm location: Hoffman Estates, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K170904 — Biograph Horizon PET/CTSiemens Medical Solutions USA, Inc.·cleared 2017-06-01

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 Horizon a) 3R, Material Number 10532746 b) 4R, Material Number 10532748 The Siemens Biograph Horizon and Biograph mCT 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

The terminals on the plug may become loose and overheat.

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