Certegra Workstation used in conjunction with Medrad Stellant CT… — Class II medical device recall Z-2768-2016
Terminated recall by Bayer Healthcare, reported 2016-09-14, distributed nationwide. CertegraWorkstation when used in conjunction with the Medrad Stellant CT Injection System may exhibit thermal
| Recall number | Z-2768-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Bayer Healthcare, Indianola, PA, United States |
| Recall initiated | 2016-08-02 |
| Classified | 2016-09-08 |
| Reported by FDA | 2016-09-14 |
| Terminated | 2016-12-09 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AU, CA, DE, ES, GB |
| Quantity | 165 systems |
| Serial numbers | KSA0517564, KSA0517565, KSA0517566, KSA0517568, KSA0517571, KSA0517574, KSA0517575, KSA0517576, KSA0517577, KSA0517581, KSA0517582, KSA0517583, KSA0517584, KSA0517587, KSA0517588, KSA0517590, KSA0517592, KSA0517595, KSA0517596, KSA0517597, KSA0517600, KSA0517602, KSA0517607, KSA0517609, KSA0517612 and 139 more |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2768-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.