Recall Z-1933-2015— Siemens Medical Solutions USA, Inc

Name: FDA recall Z-1933-2015
Creator: U.S. Food and Drug Administration
Published: 2015-06-04

Class II · Terminated

Class II FDA medical device recall by Siemens Medical Solutions USA, Inc, initiated 2015-06-04, terminated 2017-03-24. It names one FDA 510(k) clearance: K133424. Product: SOMATOM Emotion 16; produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angels or spiral planes taken at different angles.. Reason: A potential safety issue involving two (2) broken screws and one (1) bowed, which is used to fix the Balance Weight of the DMS in the gantry, was found during a service call at the customer site..

Recalling firm: Siemens Medical Solutions USA, Inc
Classification: Class II
Status: Terminated
Initiated: 2015-06-04
Terminated: 2017-03-24
Firm location: Malvern, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K133424 — SOMATOM EMOTION 6 CT SYSTEMS, SOMATOM EMOTION 16Siemens Medical Solutions USA, Inc.·cleared 2014-01-17

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

SOMATOM Emotion 16; produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angels or spiral planes taken at different angles.

Reason for recall

A potential safety issue involving two (2) broken screws and one (1) bowed, which is used to fix the Balance Weight of the DMS in the gantry, was found during a service call at the customer site.

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