Events

Recall of Device Recall syngo Workflow SLR

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Siemens Medical Solutions USA, Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    71206
  • Event Risk Class
    Class 2
  • Event Number
    Z-1704-2015
  • Event Initiated Date
    2015-05-06
  • Event Date Posted
    2015-06-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-08-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=136545
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    System, digital image communications, radiological - Product Code LMD
  • Reason
    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.
  • Action
    Siemens sent an Safety Advisory Notice, dated May 6, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were given work around instructions to follow and informed that a software fix would be implemented to permanently resolve the issue. For further questions please call (610) 219-6300.

Device

Device Recall syngo Workflow SLR
  • Model / Serial
    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
  • Product Classification
    Radiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • 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.
  • Manufacturer
    Siemens Medical Solutions USA, Inc

Manufacturer

Siemens Medical Solutions USA, Inc
  • Manufacturer Address
    Siemens Medical Solutions USA, Inc, 51 Valley Stream Pkwy, Malvern PA 19355-1406
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    USFDA