Recall Z-1705-2015— Siemens Medical Solutions USA, Inc

Name: FDA recall Z-1705-2015
Creator: U.S. Food and Drug Administration
Published: 2015-05-15

Class II · Terminated

Class II FDA medical device recall by Siemens Medical Solutions USA, Inc, initiated 2015-05-15, terminated 2017-03-24. It names 2 FDA 510(k) clearances: K123375, K092519. Product: Syngo.via and Syngo.x ; a software solution intended to be used for viewing, manipulation, communication, and storage of medical images.. Reason: measurements drawn on the 2nd and subsequent images of the series are not visible on printouts when the series is sent to print..

Recalling firm: Siemens Medical Solutions USA, Inc
Classification: Class II
Status: Terminated
Initiated: 2015-05-15
Terminated: 2017-03-24
Firm location: Malvern, PA, United States

510(k) clearances named in this recall

2 on FDA's record

K123375 — SYNGO.VIASiemens AG·cleared 2012-11-20
K092519 — SYNGO.XSiemens AG Medical Solutions·cleared 2009-08-27

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

Syngo.via and Syngo.x ; a software solution intended to be used for viewing, manipulation, communication, and storage of medical images.

Reason for recall

measurements drawn on the 2nd and subsequent images of the series are not visible on printouts when the series is sent to print.

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