Recall Z-1999-2016— Siemens Medical Solutions USA Inc.

Name: FDA recall Z-1999-2016
Creator: U.S. Food and Drug Administration
Published: 2016-04-25

Class II · Terminated

Class II FDA medical device recall by Siemens Medical Solutions USA Inc., initiated 2016-04-25, terminated 2017-02-01. It names one FDA 510(k) clearance: K123737. Product: BIOGRAPH mCT S(20) - 3R, MATERIAL NUMBER 10528956 Product Usage: The Siemens 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 bracket that is used to lift the cover has bolts that were not welded in potentially causing the cover to fall down during service..

Recalling firm: Siemens Medical Solutions USA Inc.
Classification: Class II
Status: Terminated
Initiated: 2016-04-25
Terminated: 2017-02-01
Firm location: Knoxville, TN, United States

510(k) clearances named in this recall

1 on FDA's record

K123737 — BIOGRAPH MCT FAMILYSiemens Medical Solutions USA, Inc.·cleared 2013-01-29

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 mCT S(20) - 3R, MATERIAL NUMBER 10528956 Product Usage: The Siemens 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 bracket that is used to lift the cover has bolts that were not welded in potentially causing the cover to fall down during service.

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