Aquilex Fluid Control System component: Bag deflector, REF AQL-100CBS Product Usage: Distends uterus with fluid during diagnostic and operative hysteroscopies.

The deficit displayed by the pump can differ from the real deficit, leading potentially to patient risk.

On August 14, 2019, W.O.M. World of Medicine GmbH issued a Medical Device Recall notice to their customer (distributor). On September 5, 2019, Hologic issued Medical Device Recall notices to their customers via USPS priority mail with delivery confirmation. Customers were advised to take the following actions: 1) Perform a visual check of your Aquilex system looking for obvious damage to the bag deflector using the criteria identified within the customer notice. 2) If you do not notice any obvious damage using the criteria listed within the customer letter, and your unit passes the below mentioned Fluid Deficit Test you may continue to use your unit until you receive your replacement. 3) If you notice any damage or if any of the mentioned criteria are not met please stop using your Aquilex Fluid Control system. Customers with questions, please contact Hologic Technical Support at 1-855-898-5025. A Hologic representative will assist you with your return, as well as coordinate a replacement unit for you.