Angiomat Illumena Injector with Auxiliary Console, Mallinckrodt, Inc., Hazelwood, MO.
FDA device recall Z-0056-2008 · posted 2007-10-13 · Terminated
Recall details
- Recalling firm
- Mallinckrodt Inc
- 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
- Action taken
- 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 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- DXT
- Quantity affected
- 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, Be
- Date initiated
- 2007-08-24
- Date posted
- 2007-10-13
- Date terminated
- 2010-08-17
- Location
- Cincinnati, OH
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ANGIOMAT ILLUMENA (K963071) | Mallinckrodt Inc., Liebel-Flarsheim Business | 1997-09-23 |