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.
FDA Recall Z-1686-2015 · Posted 2015-05-28
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Recalling FirmMedrad Inc dba Bayer R&I
Recall StatusTerminated
Product CodeDXT
Date Initiated2013-09-20
Date Terminated2015-06-16
Product Quantity133
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.
Firm Action
Bayer Healthcare sent a Medical Device Field Corrective Action letter to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to identify any affected device. Bayer Service will schedule time to update their software free of charge. Customers with questions were instructed to contact the customer support team at 1-800-633-7237. For questions regarding this recall call 412-767-2400.
Root Cause
Software design
Distribution Pattern
Nationwide Distribution
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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