Mallinckrodt Inc OptiVantage DH Power Injection System. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
OptiVantage DH Power Injection System.
Brand
Mallinckrodt Inc
Lot Codes / Batch Numbers
All codes.
Products Sold
All codes.
Mallinckrodt Inc is recalling OptiVantage DH Power Injection System. due to The flow rate programmed on the console may be changed without automatically updating the flow rate programmed on the power head. The injector will al. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
The recalling firm sent a letter dated 11/7/2006 to all consignees.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
PR
Page updated: Jan 10, 2026