Z-0154-06

Stellant CT Injection System. Powered Injector with Syringe. Angiographic Injector and Syringe. Model numbers...

Name: Z-0154-06 Stellant CT Injection System. Powered Injector with Syringe. Angiographic Injector and Syringe. Model numbers...
Creator: Medrad Inc
Published: 2005-10-10
License: https://open.fda.gov/license/

Medrad, Inc. / initiated 2005-10-10 / Terminated

FDA source

Medrad Inc began a recall of Stellant CT Injection System. Powered Injector with Syringe. Angiographic Injector and Syringe. Model numbers S, SX, D, and DX on 2005-10-10. The reason FDA records is "the heat maintainer, an accessory, may overheat and deform the disposable syringe". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0154-06
Status: Terminated
Initiated: 2005-10-10
Posted: 2005-11-16
Terminated: 2007-08-15
Recalling firm: Medrad, Inc.
Product: Stellant CT Injection System. Powered Injector with Syringe. Angiographic Injector and Syringe. Model numbers S, SX, D, and DX
Product code: DXT Injector And Syringe, Angiographic
Reason for recall: the heat maintainer, an accessory, may overheat and deform the disposable syringe
FDA root cause: Other
Action: The recalling firm issued an Urgent Medical Device Field Correction notice dated 10/12/05 via certified mail. The notice provided instructions to apply warning labels and disconnect the heat maintainer until a field upgrade kit is available. In case where the heat maintainer is a necessity for specific procedures, the customer is being instructed to observe certain precautions.
Quantity in commerce: 4362 units
Distribution: The products were shipped to medical facilities nationwide. The products were also shipped to Canada, Isreal, Italy, Denmark, Netherlands, Norway, Great Britain, France, Poland, Germany, Spain, Finland, Belgium, Sweden, Russia, Austraila, Cuba, Mexico, Peru, Hong Kong, Korea, Mylasia, Thialand, Taiwan, Singapore, India, China, Turkey, Saudia Arabia, and Japan
Product codes and lots: all serial numbers

Product code DXT

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)