Recall Z-1645-2015— Siemens Medical Solutions USA, Inc

Name: FDA recall Z-1645-2015
Creator: U.S. Food and Drug Administration
Published: 2015-04-20

Class II · Terminated

Class II FDA medical device recall by Siemens Medical Solutions USA, Inc, initiated 2015-04-20, terminated 2016-09-01. It names one FDA 510(k) clearance: K133424. Product: SOMATOM Emotion 16, the intended use of computed tomography is 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 angels or spiral planes taken at different angles.. Reason: Software bugs in VC20B SP0a or SP1 software versions may cause issues that could make it necessary to rescan patients. Syngo Main UI may crash if the Patient Browser is scrolled with arrow keys of the keyboard. Tomo images may freeze on the screen when zoomed in or out under the mode of CAREVision. Sporadic displaying error in WorkStream4D application. DB may lock under heavy and multitasks..

Recalling firm: Siemens Medical Solutions USA, Inc
Classification: Class II
Status: Terminated
Initiated: 2015-04-20
Terminated: 2016-09-01
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, the intended use of computed tomography is 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 angels or spiral planes taken at different angles.

Reason for recall

Software bugs in VC20B SP0a or SP1 software versions may cause issues that could make it necessary to rescan patients. Syngo Main UI may crash if the Patient Browser is scrolled with arrow keys of the keyboard. Tomo images may freeze on the screen when zoomed in or out under the mode of CAREVision. Sporadic displaying error in WorkStream4D application. DB may lock under heavy and multitasks.

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