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Incorrect screws were used for mounting the detector which may lead to a possible part falling onto a patient.
Using the product for procedures that exceed manual record mode may result in inadvertent needle stick to myocardium or blood vessel. (with ICE intracardiac imaging catheters only)
There may be an obstruction in the cannula that will prevent the guide wire from passing through it. The obstruction in the cannula can force the guidewire to advance further into the patient than intended.