Recall Z-2245-2016— Siemens Medical Solutions USA, Inc

Name: FDA recall Z-2245-2016
Creator: U.S. Food and Drug Administration
Published: 2016-06-23

Class II · Terminated

Class II FDA medical device recall by Siemens Medical Solutions USA, Inc, initiated 2016-06-23, terminated 2020-02-20. It names 2 FDA 510(k) clearances: K123375, K092519. Product: Syngo.via, picture archiving and communications system software controlled. Intended to be used for viewing, manipulation, communication, and storage of medical images.. Reason: Incorrect values for the volume calculation. Software update VB30B via Update Instructions SY018/16/P to resolve software errors..

Recalling firm: Siemens Medical Solutions USA, Inc
Classification: Class II
Status: Terminated
Initiated: 2016-06-23
Terminated: 2020-02-20
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, picture archiving and communications system software controlled. Intended to be used for viewing, manipulation, communication, and storage of medical images.

Reason for recall

Incorrect values for the volume calculation. Software update VB30B via Update Instructions SY018/16/P to resolve software errors.

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