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U.S. Department of Health and Human Services

Class 2 Device Recall Angiomat Illumena

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 Class 2 Device Recall Angiomat Illumenasee related information
Date Initiated by FirmAugust 24, 2007
Date PostedOctober 13, 2007
Recall Status1 Terminated 3 on August 17, 2010
Recall NumberZ-0056-2008
Recall Event ID 39408
510(K)NumberK963071 
Product Classification Illumena Injector with Auxiliary Console, - Product Code DXT
ProductAngiomat Illumena Injector with Auxiliary Console, Mallinckrodt, Inc., Hazelwood, MO.
Code Information Product Model Numbers : 902040; 904045; and 902045CI
FEI Number 1518293
Recalling Firm/
Manufacturer		 Mallinckrodt Inc
2111 E Galbraith Rd
Cincinnati OH 45237-1624
For Additional Information Contact
513-948-5719
Manufacturer Reason
for Recall		Synchronization problems: units that have both a main programmable console and an auxiliary programmable console, when simultaneously, injection parameters are programmed into the unit's main console and the unit's auxiliary consoles, mis-synchronization could occur resulting in a variance between the intended injection parameters (those programmed) and the actual parameters of the injection deliv
FDA Determined
Cause 2		Device Design
ActionOn 9/20/2007, a notification was sent from Mallinckrodt to all direct accounts via certified mail. The notification details the potential for mis-synchronization of injection parameters if the main and auxiliary consoles are simultaneously programmed. The notification reminds end-users that simultaneous programming should not be performed and to ensure it is not performed, a notification label (provided in the notification) is to be affixed on both consoles of the injector system. Once the label is affixed to the system, end-users are instructed to complete the notification survey and return the survey to the Mallinckrodt. In addition, the notification includes an updated chapter insert (Chapter 11.1) for the injector system's product manual that emphasize the separation between programming of the main and auxiliary consoles. Questions regarding this matter may be directed to Mallinckrodt's Product Monitoring Department at 1-888-744-1414, menu option 1 and then menu option 2.
Quantity in Commerce176
DistributionWorldwide to include:U.S.A. states of - AL, AZ, CA, CO, CT, FL, GA, HI, IA, IL, KS, KY, LA, MA, MD, MI, MN, MO, NE, NJ, NY, OH, OK, PA, TN, TX, UT, VA, WA, & WI. and Foreign countries of Argentina, Belgium, Brazil, Canada, Germany, Japan, Singapore, & Zambia.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = DXT
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