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syngo Workflow SLR; The information system syngo Workflow SLR is a digital radiology information ...

FDA Device Recall #Z-1704-2015 — Class II — May 6, 2015

Recall Summary

Recall Number Z-1704-2015
Classification Class II — Moderate risk
Date Initiated May 6, 2015
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Siemens Medical Solutions USA, Inc
Location Malvern, PA
Product Type Devices
Quantity 131

Product Description

syngo Workflow SLR; The information system syngo Workflow SLR is a digital radiology information system (RIS) with integrated modules for patient administration, examination, reporting, statistics and system administration. The system electronically displays stores, retrieves, transfers, exchanges, and prints.

Reason for Recall

A potential exists for order transactions from interfaced HIS (Hospital Information System) systems to be lost during a restart of interface processes when using the Order Batching feature, leading to diagnosis delay.

Distribution Pattern

Nationwide Distribution

Lot / Code Information

Model Number 10558586, serial numbers: 575027 322834 525352 505008 506753 366061 352179 510602 591206 195004 511709 513556 593053 380402 518357 518365 740241 625608 521609 522557 381905 523340 524009 376376 195023 528901 305185 305193 740308 195027 303602 666107 545103 195024 375014 393942 527002 485797 396416 319285 568154 375600 865808 614008 577551 577353 578708 195000 766204 195019 584805 599001 600007 304907 321778 323139 464644 611004 323170 616953 497271 312116 316935 619007 335950 620559 316208 627505 359703 697409 626952 195020 596304 499376 630558 740894 312538 195012 195021 841106 195016 688101 195007 600908 325951 316760 639005 195006 524504 522730 305086 658005 310003 652008 312298 667006 321976 195017 344275 468884 699009 470153 692756 693002 742536 314336 332007 777003 313510 822130 523803 596650 347054 314732 817007 305664 818500 822007 345710 741140 824904 824805 634600 506006 303198 827709 842302 838508 838250 451435 332296

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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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