Recall Z-2629-2023 · HIG Insufflator, Hysteroscopic

WOM World Of Medicine AG

Aquilex Fluid Control System-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. Models AQL-100PBS and AQL-100P

Date	Jan 5, 2024 (initiated Jul 17, 2023)
Status	Open, Classified
Reason	The display of inflow volume can reach its limit of 30,000 ml during long procdeure and the inflow volume display will freeze at the maximum value while the deficit will start counting backwards until 0 ml is reached and may result in fluid overload
Root cause	Software design
Action	W.O.M. World of Medicine GmbH (WOM), notified the US/Canada distributor Hologic via E-mail Urgent Field Safety Notice (FSN) - MEDICAL DEVICE RECALL Aquilex Fluid Control System Pump - REF AQL-100PBS and AQL-100P WOM reference no.: 2023-0001 on 7/17/23. Hologic notified sales representatives and the end users (hospitals and medical facilities) in the US and Canada on 8/21/2023 via Telephone calls and letter. Letter states reason for recall, health risk and action to take: W.O.M. WORLD OF MEDICINE GmbH has developed a software version, which, among others, starts emitting visual and acous
Quantity	1287 units
Distribution	Nationwide Foreign: Canada, Australia, New Zealand, Belgium, France, Germany, Ireland, Netherlands, Spain, Sweden, Norway, Switzerland, UK, Kuwait, Qatar, Turkey, UAE
FDA record	Open on fda.gov

510(k) clearances named in this recall

K172040

Aquilex Fluid Control System AQL-100S
W.O.M. World of Medicine GmbH, Feb 5, 2018