FDAFDA · Food and drugs·Recall number Z-1105-2013
Siemens syngo WorkFlow SLR, Radiological Information System, Version VA31A SP1/SP2/SP3 The information system syngo(R) Workflow SLR is a digital radiology information system (RIS) with integrated modules for patient administration, examination, reporting, statistics and system administration, as well as multiple interfaces for patient registration, order entry, and external billing modules. It is not intended to treat disease or administer any medicinal substances or drugs. There is no contact between device and patient. syngo(R) Workflow SLR can be used as a separate RIS, interfacing to a Hospital Information System (HIS) or Picture Archiving and Communication Systems (PACS
Published April 24, 2013 · Recall initiated: October 5, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Distributor
- 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 of Canada and Australia.
- Lot
- Model numbers 10558922, 10558933 and 10558980 with software version VA31A SP1/SP2/SP3
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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