MEDRAD¿ Stellant CT Injector System with Certegra Workstation — Class II medical device recall Z-1686-2015
Terminated recall by Medrad Inc dba Bayer R&I, reported 2015-06-03, distributed nationwide. The root cause investigation showed that the under-volume hazard can occur when the unit has been configured t
| Recall number | Z-1686-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medrad Inc dba Bayer R&I, Indianola, PA, United States |
| Recall initiated | 2013-09-20 |
| Classified | 2015-05-28 |
| Reported by FDA | 2015-06-03 |
| Terminated | 2015-06-16 |
| Distributed | Nationwide (US) |
| Quantity | 133 |
| Serial numbers | 10008, 10010, 10026, 10027, 10028, 10030, 10032, 10035, 10054, 10058, 10064, 10065, 10069, 10076, 10091, 10093, 10095, 10107, 10123, 10127, 10145, 10212, 10280, 108, 20092 and 111 more |
Product
MEDRAD¿ Stellant CT Injector System with Certegra Workstation; intended for the specific purpose of injecting intravenous contrast media into humans for diagnostic studies in computed tomography (CT) applications.
Reason for recall
The root cause investigation showed that the under-volume hazard can occur when the unit has been configured to prime with contrast, but instead primes with saline due to the configuration data not being sent to the injector head. This may create a non-optimal priming condition that could lead to under-infusion.
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-1686-2015. 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.