Recall Z-1105-2013— Siemens Medical Solutions USA, Inc

Class II FDA medical device recall by Siemens Medical Solutions USA, Inc, initiated 2012-10-05, terminated 2013-07-16. FDA's recall record names no specific 510(k) clearance for this event. Product: 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. Reason: 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.

Recalling firm

Siemens Medical Solutions USA, Inc

Classification

Class II

Status

Terminated

Initiated

2012-10-05

Terminated

2013-07-16

Firm location

Malvern, PA, United States

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