FDA Device recall Z-2768-2016
Certegra Workstation used in conjunction with Medrad Stellant CT Injection System Catalog Number # CWKS DISPLAY Serial Numbers The Medrad S…
- FDA Device
- Class II
- terminated
- Published 2016-09-14
On 2016-09-14 the FDA classified a Class II recall of Certegra Workstation used in conjunction with Medrad Stellant CT Injection System Catalog Number # CWKS DISPLAY Serial Numbers The Medrad S… by Bayer Healthcare, citing certegraWorkstation when used in conjunction with the Medrad Stellant CT Injection System may exhibit thermal events, such as: smoke and sparks of fire.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2768-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-08-02 |
| Published | 2016-09-14 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Bayer Healthcare |
| Distribution | US |
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
Reason
CertegraWorkstation when used in conjunction with the Medrad Stellant CT Injection System may exhibit thermal events, such as: smoke and sparks of fire.
Identifiers
| code_info | Serial Numbers: KSA0517595 KSA0518535 KSA0519948 KSA0518539 KSA0518498 KSA0517618 KSA0518500D KSA0518536 KSA0…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 KSA051847 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2768-2016%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.