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.
FDA Recall Z-1643-2008 · Posted 2008-08-24
Advertisement
Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeLLZ
Date Initiated2008-03-10
Date Terminated2008-11-19
Product Quantity236 units
Reason for Recall
The firm discovered a problem where the selected patient images on the device may display an additional image from another patient or study.
Firm 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 2008-03-06.
Root Cause
Software design
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement