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U.S. Department of Health and Human Services

Class 2 Device Recall MEDRAD Stellant CT Injector System with Certegra

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  Class 2 Device Recall MEDRAD Stellant CT Injector System with Certegra see related information
Date Initiated by Firm September 20, 2013
Date Posted May 28, 2015
Recall Status1 Terminated 3 on June 16, 2015
Recall Number Z-1686-2015
Recall Event ID 71296
510(K)Number K082905  
Product Classification Injector and syringe, angiographic - Product Code DXT
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.
Code Information Material numbers: 3032458, 3007301, 3010432 with serial numbers: 10054 37918 37921 36714 36721 108 40596 23834 10065 39533 20092 29884 33423 10026 10028 10032 10035 10069 29881 30351 23741 27877 10095 20693 30548 33316 21089 10123 10008 24272 37177 25989 39003 39009 38894 38894 38840 38843 34894 38833 35824 38846 26107 37073 37472 10058 10010 10076 24707 10091 38400 38403 38404 38405 40390 10093 38999 39434 37351 37359 37358 37367 40225 34619 10127 38989 37298 37461 37462 35172 35173 35175 35176 34630 25348 36811 33443 36432 38007 31538 33315 35434 20178 25804 10280 28893 31196 35454 38011 29248 30219 39034 38940 36975 23511 36937 36966 36086 10030 10027 37839 35554 33020 10212 10145 38631 31620 37996 38906 39201 38659 31537 33314 38895 39049 38930 38319 38995 38996 38678 30429 30540 10064 38322 38196 38197 39509 33230 38831 10107 37431 26933 39171 39191 34829 37684 41169 
Recalling Firm/
Manufacturer		 Medrad Inc dba Bayer R&I
1 Medrad Dr
Indianola PA 15051-9759
For Additional Information Contact Customer Support
412-767-2400
Manufacturer 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.
FDA Determined
Cause 2		 Software design
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.
Quantity in Commerce 133
Distribution Nationwide Distribution
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = DXT and Original Applicant = MEDRAD, INC.
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