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Syngo.via and Syngo.x ; a software solution intended to be used for viewing, manipulation, commun...

FDA Device Recall #Z-1705-2015 — Class II — May 15, 2015

Recall Summary

Recall Number Z-1705-2015
Classification Class II — Moderate risk
Date Initiated May 15, 2015
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Siemens Medical Solutions USA, Inc
Location Malvern, PA
Product Type Devices
Quantity 167

Product Description

Syngo.via and Syngo.x ; a software solution intended to be used for viewing, manipulation, communication, and storage of medical images.

Reason for Recall

measurements drawn on the 2nd and subsequent images of the series are not visible on printouts when the series is sent to print.

Distribution Pattern

Nationwide Distribution

Lot / Code Information

Model Number of device: 10496180, with serial numbers: 220755 101060 100509 220783 100662 220844 130208 102213 100862 101739 102125 102401 102402 130118 102024 102509 102477 102008 100751 101802 102089 101559 102407 130252 220915 220909 130267 101118 101313 101114 130180 100735 100495 102295 102532 220684 220725 102265 101638 102377 101432 102158 101864 130161 102374 102025 220511 102340 102197 101938 101647 100929 220206 100729 101201 101051 101220 101202 101206 101854 220448 220466 101565 100530 101612 102381 101561 220879 130174 102100 102418 100220 102120 220593 101137 101740 220577 102336 130125 101701 102335 101419 100748 101885 101578 101341 100460 102108 102175 100692 130122 101371 130378 100675 100700 101257 130229 220617 102021 100760 101338 102281 100718 101309 220888 101631 220920 100796 102405 220512 102435 100075 101444 100957 100039 102417 101043 101042 101066 220521 102127 101546 100705 220855 102420 102146 220742 102486 101797 101754 100633 102363 220743 130266 220454 100603 102074 101953 102173 102063 100892 100753 102163 220876 130140 130269 100734 101316 100845 101958 101200 101852 100484 220900 101038 101057 102355 100978 102014 130173 100917 101266 100389 101010 101650 100742 102360

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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.

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