FDA Device

OptiVantage DH Power Injection System.

Hazard

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.

What You Should Do

Remedy

The recalling firm sent a letter dated 11/7/2006 to all consignees.

Products

OptiVantage DH Power Injection System.
Brand
Mallinckrodt Inc
UPC
All codes.

Units Affected

1348 devices.