H3, h6: the real intelligence cori, rob10024, serial number (b)(6) intended for used in treatment was not returned for evaluation.A visual or functional inspection could not be performed and the reported problem could not be visually or functional confirmed.A review of manufacturing and service records indicate the device met all specifications upon release into distribution.A complaint history review for similar reported/confirmed complaints has identified prior events.Although the reported problem was not confirmed, a contributing factor may be associated with a software bug.Although no further containment or corrective action is recommended or required at this time, all complaints are monitored and trended through post market surveillance activities.
|