Recall Z-0960-2015— Siemens Medical Solutions USA, Inc.

Name: FDA recall Z-0960-2015
Creator: U.S. Food and Drug Administration
Published: 2014-03-05

Class II · Terminated

Class II FDA medical device recall by Siemens Medical Solutions USA, Inc., initiated 2014-03-05, terminated 2016-12-23. It names one FDA 510(k) clearance: K082506. Product: Symbia T and Symbia T2 computer tomography systems. These systems are used to perform SPECT, CT, and SPECT + CT scans and imaging studies.. Reason: There are confirmed reports of a component coming loose inside the CT enclosure and damaging the system. components..

Recalling firm: Siemens Medical Solutions USA, Inc.
Classification: Class II
Status: Terminated
Initiated: 2014-03-05
Terminated: 2016-12-23
Firm location: Hoffman Estates, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K082506 — SYMBIA, VERSION 4.0Siemens Medical Solutions USA, Inc.·cleared 2008-11-21

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

Symbia T and Symbia T2 computer tomography systems. These systems are used to perform SPECT, CT, and SPECT + CT scans and imaging studies.

Reason for recall

There are confirmed reports of a component coming loose inside the CT enclosure and damaging the system. components.

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