Siemens syngo WorkFlow SLR, Radiological Information System, Version VA31A SP1/SP2/SP3 The information system syngo(R) W

FDA device recall Z-1105-2013 · posted 2013-04-12 · Terminated

Recall details

Recalling firm

Siemens Medical Solutions USA, Inc

Reason for recall

Under certain conditions, when using the Search functionality, the potential exists for the wrong patient's Interactive Documents to display when viewing a signed report in the single patient view. This can occur when the Interactive Document is viewed or auto displayed, dismissed by the user, and then a different patient and signed exam is selected in single patient view. The Notes Viewer will

Action taken

Siemens Medical sent a Customer Safety Advisory Notice letter dated October 5, 2012 , to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. There will be a Hot Fix available. If you have any further questions please contact Siemens Customer Product Support at (1-888) 767-8326.

Root cause

Software design

Status

Terminated

Product code

LLZ

Quantity affected

37

Distribution

Worldwide Distribution - USA including the states of AL, CA, CO, DC, DE, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MO, NC, NE, NH, NJ, NV, NY, OH, OR, PA, TN, TX, VA, WI, WV, and WY. and the countries o

Date initiated

2012-10-05

Date posted

2013-04-12

Date terminated

2013-07-16

Location

Malvern, PA