Recall Z-2629-2023
WOM World Of Medicine AG · initiated July 17, 2023
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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
Codes / lots: UDI-DI: 04056702006914 Device Models AQL-100PBS and AQL-100P Serial Numbers: US S1802CE0538 1802CE0539 1802CE0540 1802CE0542 1802CE0543 1802CE0544 1802CE0545 1802CE0546 1802CE0547 1802CE0616 1802CE0617 1802CE0618 1802CE0619 1802CE0620 1802CE0621 1802CE0622 1802CE0624 1802CE0625 1802CE0648 1802CE0649 1802CE0651 1802CE0652 1802CE0653 1802CE0654 1802CE0655 1802CE0656 1802CE0657 1803CE0121 1803CE0122 1803CE0123 1803CE0124 1803CE0125 1803CE0126 1803CE0127 1803CE0128 1803CE0129 1803CE0130 1803CE0199 1803CE0201 1803CE0204 1803CE0205 1803CE0295 1803CE0296 1803CE0298 1803CE0299 1803CE0300 1803CE0301 1803CE0302 1803CE0663 1803CE0909 1803CE0910 1803CE0911 1803CE0912 1803CE0913 1803CE0914 1803CE0915 1803CE0916 1803CE0917 1803CE0918 1803CE0984 1803CE0985 1803CE0986 1803CE0987 1803CE0988 1803CE0989 1803CE0990 1803CE0991 1803CE0992 1803CE1014 1803CE1015 1803CE1016 1803CE1017 1803CE1018 1803CE1019 1803CE1020 1803CE1021 1803CE1022 1803CE1023 1803CE1088 1803CE1089 1803CE1090 1803CE1091 1803CE1092 1803CE1093 1803CE1094 1803CE1095 1803CE1096 1803CE1097 1803CE1129 1803CE1131 1803CE1132 1803CE1134 1803CE1135 1803CE1136 1803CE1137 1803CE1178 1803CE1179 1803CE1180 1803CE1181 1803CE1183 1803CE1185…
Reason for recall
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
FDA-determined cause: Software design
Action taken
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 acoustic signals when an inflow volume of 28,000 ml is reached. Additionally, the system will pause when an inflow volume of 30,000 ml is reached and is designed to prepare the user for a manual fluid deficit determination. Action To Be Taken by the User: Ensure that the affected devices receive their preventive maintenance on time, every two years, as prescribed by the manufacturer. A new software version and an updated version of the IFU are implemented during the next due preventive maintenance of the pump of the Aquilex Fluid Control Systems AQL-100PBS as well as AQL-100P. Also, please complete Customer Acknowledgement Form (Annex 2). This notice should be provided to all personnel who need to be made aware of this issue within your organization.
Details
- Recall number
- Z-2629-2023
- Initiated
- July 17, 2023
- Posted by FDA
- January 5, 2024
- Product code
- HIG – Insufflator, Hysteroscopic
- Quantity
- 1287 units
- Distribution
- Nationwide Foreign: Canada, Australia, New Zealand, Belgium, France, Germany, Ireland, Netherlands, Spain, Sweden, Norway, Switzerland, UK, Kuwait, Qatar, Turkey, UAE
- Recalling firm
- WOM World Of Medicine AG, Ludwigsstadt