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.

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    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
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Siemens Medical Solutions USA, Inc
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.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full 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.

Product Codes/Lot Numbers:

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

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1704-2015

Related Recalls

During patient examinations, the system may sporadically display a 0 x-ray dose administered to the patient. This behavior has only been observed during fluoroscopy and/or single-frame acquisitions. Despite the reported x-ray dose showing 0, an actual x-ray dose is applied to the patient.

Mar 9, 2026 Other Medical Devices View Details →
Class I - Dangerous

During patient examinations, the system may sporadically display a 0 x-ray dose administered to the patient. This behavior has only been observed during fluoroscopy and/or single-frame acquisitions. Despite the reported x-ray dose showing 0, an actual x-ray dose is applied to the patient.

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During 3D acquisitions, lighter and darker patient images may be captured, which may result in less accurate 3D reconstruction. The variation of brightness is a result of a constant unregulated medium dose and the angular change of patient diameter caused by rotational acquisition. This may result in unintentional low-dose radiation exposure to a patient.

Mar 12, 2026 Other Medical Devices View Details →