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U.S. Department of Health and Human Services

Class 2 Device Recall Stellant with Certegra Workstation

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  Class 2 Device Recall Stellant with Certegra Workstation see related information
Date Initiated by Firm August 02, 2016
Create Date September 08, 2016
Recall Status1 Terminated 3 on December 09, 2016
Recall Number Z-2768-2016
Recall Event ID 74974
510(K)Number K082905  
Product Classification Injector and syringe, angiographic - Product Code DXT
Product Certegra Workstation used in conjunction with Medrad Stellant CT Injection System
Catalog Number # CWKS DISPLAY
Serial Numbers
The Medrad Stellant CT Injector System is intended for the specific purpose of injecting intravenous contrast media into humans for diagnostic studies in computed tomography (CT) applications
Code Information Serial Numbers:  KSA0517595 KSA0518535 KSA0519948 KSA0518539 KSA0518498 KSA0517618 KSA0518500D KSA0518536 KSA0518456 KSA0518504 KSA0518520 KSA0519940 KSA0518507 KSA0519991 KSA0517568 KSA0517592 KSA0517649 KSA0518496 KSA0518508 KSA0519971 KSA0518534 KSA0517600 KSA0517566 KSA0517587 KSA0518469 KSA0518452 KSA0518460 KSA0518532 KSA0518516 KSA0519946 KSA0517641 KSA0519968 KSA0519941 KSA0518399 KSA0518479 KSA0517609 KSA0517617 KSA0518446 KSA0518453 KSA0518410 KSA0518466 KSA0517581 KSA0517574 KSA0518524 KSA0519956 KSA0518459 KSA0518495 KSA0518481 KSA0518513 KSA0518528 KSA0519989 KSA0518429 KSA0518523 KSA0517620 KSA0518509 KSA0517634 KSA0519964 KSA0518418 KSA0518474 KSA0518526 KSA0518468 KSA0518499 KSA0518463 KSA0517571 KSA0517648 KSA0517564 KSA0517644 KSA0518423 KSA0517582 KSA0518427 KSA0518518 KSA0518419 KSA0518397 KSA0518505 KSA0518522 KSA0517660 KSA0518492 KSA0519955 KSA0517629 KSA0518461 KSA0519951 KSA0518471 KSA0517597 KSA0517565 KSA0517656 KSA0518506 KSA0517607 KSA0517659 KSA0518491 KSA0517632 KSA0519978 KSA0517590 KSA0517612 KSA0517613 KSA0518447 KSA0518424 KSA0518400 KSA0519939 KSA0518431 KSA0518435 KSA0518515 KSA0518490 KSA0517624 KSA0518455 KSA0517661 KSA0518493 KSA0519945 KSA0517575 KSA0517588 KSA0517616 KSA0517653 KSA0517657 KSA0517658 KSA0518449 KSA0519982 KSA0519959 KSA0518426 KSA0519984 KSA0519976 KSA0519952 KSA0518511 KSA0518540 KSA0517584 KSA0517651 KSA0519947 KSA0518413 KSA0518405 KSA0518502 KSA0519954 KSA0519980 KSA0518531 KSA0518443 KSA0518529 KSA0519972 KSA0518510 KSA0517637 KSA0519990 KSA0518484 KSA0517602 KSA0518437 KSA0518477 KSA0517583 KSA0518530 KSA0518412 KSA0517577 KSA0519958 KSA0518442 KSA0518525 KSA0517635 KSA0517662 KSA0519957 KSA0519961 KSA0519981 KSA0518521 KSA0517646 KSA0518464 KSA0517576 KSA0518420 KSA0518433 KSA0519960 KSA0518414 KSA0517596 KSA0519970 KSA0518473 
Recalling Firm/
Manufacturer		 Bayer Healthcare
1 Bayer Dr
Indianola PA 15051-9702
For Additional Information Contact
412-767-2400
Manufacturer Reason
for Recall		 CertegraWorkstation when used in conjunction with the Medrad Stellant CT Injection System may exhibit thermal events, such as: smoke and sparks of fire.
FDA Determined
Cause 2		 Under Investigation by firm
Action Bayer Healthcare mailed an Urgent Field Safety Notification letter on August 03, 2016 to customers who were affected by the recall informing them of the issue and what actions to take if they were impacted. Customers were advised to use the enclosed Interim Instructions for Use for further information. For questions customers should call 1-877-229-3767.
Quantity in Commerce 165 systems
Distribution Worldwide Distribution - US (nationwide) and Internationally to United Arab Emirates, Australia, Canada, Germany, Spain, and United Kingdom.
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.
510(K) Database 510(K)s with Product Code = DXT and Original Applicant = MEDRAD, INC.
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