Recall Z-1721-2014— Siemens Medical Solutions USA, Inc

Name: FDA recall Z-1721-2014
Creator: U.S. Food and Drug Administration
Published: 2014-03-21

Class II · Terminated

Class II FDA medical device recall by Siemens Medical Solutions USA, Inc, initiated 2014-03-21, terminated 2015-03-16. It names 3 FDA 510(k) clearances: K050297, K042328, K023687. Product: Siemens SOMATOM Emotion 16, Emotion 6, and SOMATOM Spirit Computed Tomography Systems Product Usage: To produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles.. Reason: The rubber damper may degrade and break, causing loosening of the motor mounting plates, which could lead to a series of events that could place the operator and patient at risk of injury..

Recalling firm: Siemens Medical Solutions USA, Inc
Classification: Class II
Status: Terminated
Initiated: 2014-03-21
Terminated: 2015-03-16
Firm location: Malvern, PA, United States

510(k) clearances named in this recall

3 on FDA's record

K050297 — SOMATOM EMOTION 16Siemens Medical Solution, Inc. USA·cleared 2005-03-01
K042328 — SOMATOM SPIRITSiemens Medical Systems, Inc.·cleared 2004-09-14
K023687 — SOMATOM EMOTION 6 CT SYSTEMSSiemens Medical Systems, Inc.·cleared 2002-11-22

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

Siemens SOMATOM Emotion 16, Emotion 6, and SOMATOM Spirit Computed Tomography Systems Product Usage: To produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles.

Reason for recall

The rubber damper may degrade and break, causing loosening of the motor mounting plates, which could lead to a series of events that could place the operator and patient at risk of injury.

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