Recall Z-0056-2008 ยท DXT Injector And Syringe, Angiographic
Mallinckrodt Inc
Angiomat Illumena Injector with Auxiliary Console, Mallinckrodt, Inc., Hazelwood, MO.
| Date | Oct 13, 2007 (initiated Aug 24, 2007) |
| Status | Terminated |
| Reason | 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 |
| Root cause | Device Design |
| Action | On 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 retur |
| Quantity | 176 |
| Distribution | Worldwide 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K963071 | ANGIOMAT ILLUMENA Mallinckrodt Inc., Liebel-Flarsheim Business, Sep 23, 1997 |