Siemens syngo WorkFlow SLR, Radiological Information System, Version VA31A SP1/SP2/SP3 The in...
FDA Device Recall #Z-1105-2013 — Class II — October 5, 2012
Recall Summary
| Recall Number | Z-1105-2013 |
| Classification | Class II — Moderate risk |
| Date Initiated | October 5, 2012 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Siemens Medical Solutions USA, Inc |
| Location | Malvern, PA |
| Product Type | Devices |
| Quantity | 37 |
Product Description
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 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
Distribution Pattern
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 / Code Information
Model numbers 10558922, 10558933 and 10558980 with software version VA31A SP1/SP2/SP3
Other Recalls from Siemens Medical Solutions USA, Inc
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1175-2026 | Class II | Interventional Fluoroscopic X-Ray System: LUMIN... | Dec 29, 2025 |
| Z-1174-2026 | Class II | Interventional Fluoroscopic X-Ray System: LUMIN... | Dec 29, 2025 |
| Z-1241-2026 | Class II | NAEOTOM Alpha.Prime Software applications: s... | Dec 19, 2025 |
| Z-1240-2026 | Class II | NAEOTOM Alpha Software applications: syngo.C... | Dec 19, 2025 |
| Z-1239-2026 | Class II | SOMATOM X.ceed Software applications: syngo.... | Dec 19, 2025 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.