Z-0056-2008

Angiomat Illumena Injector with Auxiliary Console, Mallinckrodt, Inc., Hazelwood, MO

Name: Z-0056-2008 Angiomat Illumena Injector with Auxiliary Console, Mallinckrodt, Inc., Hazelwood, MO
Creator: Mallinckrodt Inc
Published: 2007-08-24
License: https://open.fda.gov/license/

Mallinckrodt, Inc. / initiated 2007-08-24 / Terminated / root cause: design

FDA source

Mallinckrodt Inc began a recall of Angiomat Illumena Injector with Auxiliary Console, Mallinckrodt, Inc., Hazelwood, MO on 2007-08-24. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0056-2008
Status: Terminated
Initiated: 2007-08-24
Posted: 2007-10-13
Terminated: 2010-08-17
Recalling firm: Mallinckrodt, Inc.
Product: Angiomat Illumena Injector with Auxiliary Console, Mallinckrodt, Inc., Hazelwood, MO.
Product code: DXT Injector And Syringe, Angiographic
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
Root cause tag: design
FDA 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 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 commerce: 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.
Product codes and lots: Product Model Numbers : 902040; 904045; and 902045CI

Product code DXT

K963071Class IIAngiomat IllumenaMallinckrodt Inc., Liebel-Flarsheim Business / cleared 1997-09-23

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)