Certegra Workstation used in conjunction with Medrad Stellant CT Injection System
Medical device recall Z-2768-2016. Published in FDA’s Enforcement Report on Sep 14, 2016.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Sep 14, 2016. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 165 systems how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
CertegraWorkstation when used in conjunction with the Medrad Stellant CT Injection System may exhibit thermal events, such as: smoke and sparks of fire.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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
165 systems, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial Numbers: KSA0517595 KSA0518535 KSA0519948 KSA0518539 KSA0518498 KSA0517618 KSA0518500D KSA0518536 KSA0518456 KSA0518504 KSA0518520 KSA0519940 KSA0518507 KSA0519991 KSA0517568 KSA0517592 KSA0517649 KSA0518496 KSA0518508 KSA0519971…
Every code shown here, 1,820 characters
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
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Worldwide Distribution - US (nationwide) and Internationally to United Arab Emirates, Australia, Canada, Germany, Spain, and United Kingdom.
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Aug 2, 2016.
- FDA classified it on Sep 8, 2016.
- FDA’s Enforcement Report published it on Sep 14, 2016.
- FDA terminated it on Dec 9, 2016.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Bayer Healthcare, of Indianola, PA.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.