Recall Z-1686-2015— Medrad Inc dba Bayer R&I
Class II · Terminated
Class II FDA medical device recall by Medrad Inc dba Bayer R&I, initiated 2013-09-20, terminated 2015-06-16. It names one FDA 510(k) clearance: K082905. 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: 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..
- Recalling firm
- Medrad Inc dba Bayer R&I
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-09-20
- Terminated
- 2015-06-16
- 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
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.