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U.S. Department of Health and Human Services

Class 2 Device Recall syngo Workflow SLR

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  Class 2 Device Recall syngo Workflow SLR see related information
Date Initiated by Firm May 06, 2015
Date Posted June 02, 2015
Recall Status1 Terminated 3 on August 17, 2016
Recall Number Z-1704-2015
Recall Event ID 71206
Product Classification System, digital image communications, radiological - Product Code LMD
Product 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.
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   
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
51 Valley Stream Pkwy
Malvern PA 19355-1406
For Additional Information Contact Customer Support
610-219-6300
Manufacturer 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.
FDA Determined
Cause 2		 Software design
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.
Quantity in Commerce 131
Distribution Nationwide Distribution
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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