Cl ll Siemens syngo WorkFlow SLR

Company:Siemens Medical Solutions USA, Inc.
Date of Enforcement Report 4/24/2013
Class ll:

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) Recall Number Z-1105-2013

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 display Interactive Document notes for the previously selected patient. The problem is when a signed report is selected, the internal list of selected exams is not being reset. The potential for a safety issue occurs when the Radiologist selects a signed report for a patient and then selects a signed report for a different patient. If the Radiologist is performing an addend on the second signed report and bases the addend on information from the incorrect note, this could then contribute to an incorrect diagnosis if this is not recognized by the Radiologist. Furthermore, if the Radiologist creates and saves a new note, the note could be saved against the previously selected patient

RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc., Martinez, CA, on 10/5/2012. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
37 units

DISTRIBUTION
Nationwide and Internationally

___________________________________

About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

What’s New

FDA:  Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices

Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:  https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/exemptions-variances-and-alternate-forms-adverse-event-reporting-medical-devices

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.