Z-0288-2007

OptiVantage DH Power Injection System

Name: Z-0288-2007 OptiVantage DH Power Injection System
Creator: Mallinckrodt Inc
Published: 2006-11-07
License: https://open.fda.gov/license/

Mallinckrodt, Inc. / initiated 2006-11-07 / Terminated

FDA source

Mallinckrodt Inc began a recall of OptiVantage DH Power Injection System on 2006-11-07. The reason FDA records is "The flow rate programmed on the console may be changed without automatically updating the flow rate programmed on the power head. The injector will always inject in accordance with the parameters shown on the power...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0288-2007
Status: Terminated
Initiated: 2006-11-07
Posted: 2006-12-16
Terminated: 2007-07-21
Recalling firm: Mallinckrodt, Inc.
Product: OptiVantage DH Power Injection System.
Product code: CXT
Reason for recall: The flow rate programmed on the console may be changed without automatically updating the flow rate programmed on the power head. The injector will always inject in accordance with the parameters shown on the power head. If this lack of synchronization occurs and is not noticed by the clinican, contrast would be injected at a higher or lower flow rate than desired.
FDA root cause: Other
Action: The recalling firm sent a letter dated 11/7/2006 to all consignees.
Quantity in commerce: 1348 devices.
Distribution: Worldwide distribution ---- including USA and countries of Australia, Belgium, Brazil, Canada, Chile, Columbia, Denmark, Mexico, Panama, Puerto Rico, Singapore and South Africa.
Product codes and lots: All codes.

Product code CXT

K042744Class IIOptiv Antage Dh Power Injection SystemMallinckrodt Inc., Liebel-Flarsheim Business / cleared 2004-11-30

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)