Recall Z-2768-2016— Bayer Healthcare
Class II · Terminated
Class II FDA medical device recall by Bayer Healthcare, initiated 2016-08-02, terminated 2016-12-09. It names one FDA 510(k) clearance: K082905. 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..
- Recalling firm
- Bayer Healthcare
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-08-02
- Terminated
- 2016-12-09
- Firm location
- Indianola, PA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.