Recall Z-2334-2015— Siemens Medical Solutions USA Inc.

Name: FDA recall Z-2334-2015
Creator: U.S. Food and Drug Administration
Published: 2015-07-14

Class II · Terminated

Class II FDA medical device recall by Siemens Medical Solutions USA Inc., initiated 2015-07-14, terminated 2016-03-03. It names one FDA 510(k) clearance: K123737. Product: SYS IVK, Bio mCT-S(40) 3R->4R, Model Number 10250743. Reason: Emission computed tomography systems and computed tomography xray systems with optional ceiling mounts may be missing a locking ring..

Recalling firm: Siemens Medical Solutions USA Inc.
Classification: Class II
Status: Terminated
Initiated: 2015-07-14
Terminated: 2016-03-03
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

SYS IVK, Bio mCT-S(40) 3R->4R, Model Number 10250743

Reason for recall

Emission computed tomography systems and computed tomography xray systems with optional ceiling mounts may be missing a locking ring.

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