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U.S. Department of Health and Human Services

Class 2 Device Recall Aquilex Fluid Control System

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  Class 2 Device Recall Aquilex Fluid Control System see related information
Date Initiated by Firm July 17, 2023
Date Posted January 05, 2024
Recall Status1 Open3, Classified
Recall Number Z-2629-2023
Recall Event ID 92938
510(K)Number K172040  
Product Classification Insufflator, hysteroscopic - Product Code HIG
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
Code Information 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 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2303CE0503 2303CE0504 2303CE0505 2303CE0506 2303CE0601 2303CE0602 2303CE0603 2303CE0604 2303CE0605 2303CE0606 2303CE0607 2303CE0608 2303CE0609 2303CE0610 2303CE0651 2303CE0652 2303CE0653 2303CE0654 2303CE0655 2303CE0656 2303CE0657 2303CE0658 2303CE0659 2303CE0660 2303CE0661 Serial Numbers: Canada 1802CE0650 1803CE0302 1803CE0662 1803CE1128 1803CE1184 1804CE0136 1804CE0141 1804CE0618 1804CE0627 1804CE0753 1804CE0754 1804CE0756 1805CE0044 1805CE0175 1805CE0260 1805CE0265 1805CE0558 1805CE0559 1807CE0299 1807CE0354 1807CE0356 1807CE0358 1808CE1123 1808CE1127 1808CE1130 1808CE1229 1809CE0249 1809CE1058 1811CE0775 1811CE0900 1811CE0902 1811CE0904 1811CE0906 1902CE0595 1902CE0597 1902CE0634 1902CE0754 1902CE0756 1903CE0535 1903CE0563 1903CE0790 1904CE0752 1904CE0753 1904CE0755 1904CE0756 1904CE0757 1904CE0802 1904CE0805 1904CE0806 1904CE0807 1904CE0809 1904CE0810 1906CE0361 1906CE0362 1906CE0365 1906CE0366 1906CE0713 1906CE0717 1906CE0718 1906CE0755 1906CE0757 1906CE0759 1906CE0761 1906CE0763 1906CE0947 1908CE0824 1908CE0830 1911CE1153 1911CE1154 1911CE1156 1912CE0358 1912CE0359 1912CE0361 2002CE1061 2002CE1062 2002CE1063 2002CE1064 2002CE1065 2002CE1066 2002CE1067 2006CE0063 2006CE0876 2006CE0885 2008CE0109 2010CE0991 2102CE0326 2103CE0809 2104CE0706
Recalling Firm/
Manufacturer		 WOM World Of Medicine AG
Alte Poststr. 11
Ludwigsstadt Germany
Manufacturer 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 2		 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 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.
Quantity in Commerce 1287 units
Distribution Nationwide Foreign: Canada, Australia, New Zealand, Belgium, France, Germany, Ireland, Netherlands, Spain, Sweden, Norway, Switzerland, UK, Kuwait, Qatar, Turkey, UAE
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = HIG and Original Applicant = W.O.M. World Of Medicine GmbH
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