Recall Z-1643-2008 · LLZ System, Image Processing, Radiological

Siemens Medical Solutions USA, Inc

Syn go Imaging XS is a picture archiving and communication system intended to display, process, read, report, communicate, distribute, store and archive digital radiological images, including digital mammography images.

Date	Aug 24, 2008 (initiated Mar 10, 2008)
Status	Terminated
Reason	The firm discovered a problem where the selected patient images on the device may display an additional image from another patient or study.
Root cause	Software design
Action	The recalling firm issued a Customer Safety Advisory via certified mail to affected customers per Update Instructions IM011/08/S. The letter informs customers of the potential issue and provides instructions to detect its occurrence. A software update to correct the issue is already available. A service representative will visit affected sites to install the software update. If you have questions concerning the advisory letter or you did not receive a letter contact Alexander Vogel at +49 (9131) 84-3840 or alexander.vogel@siemens,com and make reference to complaint 08-1KM-0073 date 2008-03-0
Quantity	236 units
Distribution	The product was shipped to medical facilities in AL, AZ, CA, CO, CT, FL, GA, IA, KS, KY, MD, MI, MN, MO, NC, ND, NE, NJ, NM, NV, NY, OH, OK, PA, TN, TX, WI, and WV.
FDA record	Open on fda.gov

510(k) clearances named in this recall

K071114

SYNGO IMAGING (VERSION V30)
Siemens AG Medical Solutions, May 22, 2007