Recall record at a glance
| Official record | Z-2768-2016 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Bayer Healthcare |
| Report date | Sep 14, 2016 |
| Recall initiation date | Aug 2, 2016 |
| Quantity | 165 systems |
| Location | Indianola, PA, United States |
Official product description
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
Why the product was recalled
CertegraWorkstation when used in conjunction with the Medrad Stellant CT Injection System may exhibit thermal events, such as: smoke and sparks of fire.
Distribution information
Worldwide Distribution - US (nationwide) and Internationally to United Arab Emirates, Australia, Canada, Germany, Spain, and United Kingdom.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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