The Aquilex Fluid Control System is intended to provide fluid distension of the uterus during diagnostic and operative hysteroscopies and to monitor the volume differential between the irrigation fluid flowing into and out of the uterus. W.O.M. had received several complaints about deficit issues in the past. The manufacturer has observed that Aquilex Fluid Management Systems were used even though the system was mechanically damaged, or the deficit function was out of specification due to overdue preventive maintenance of the device. Failure investigation performed on complaint units indicates that the function test that is stipulated in the IFU is not always performed. The IFU stipulates that a function test must be performed before the system is used to detect a malfunction of the device at an early stage. The users should become more aware and perform the function tests, which detects any kind of deviation of the deficit measurement function. Therefore, W.O.M. will perform a product field action to add a 1000 g weight to the packaging of the pump and add the new labelling during biannually preventive maintenance. After preventive maintenance an information letter is enclosed with the device which explains the changes to labeling and the execution of the function test. Recall Start Date: May 28, 2021 Recall End Date: June 21, 2024 Old recall initiated in 2021 and web-posted delayed in September 2024 (closing date: 2024-06-21)
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