Aquilex Fluid Control System-Intended to provide fluid distension of the uterus during diagnostic and operative hysteros
FDA device recall Z-2629-2023 · posted 2024-01-05 · Open, Classified
Recall details
- Recalling firm
- WOM World Of Medicine AG
- 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
- 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.
- Root cause
- Software design
- Status
- Open, Classified
- Product code
- HIG
- Quantity affected
- 1287 units
- Distribution
- Nationwide Foreign: Canada, Australia, New Zealand, Belgium, France, Germany, Ireland, Netherlands, Spain, Sweden, Norway, Switzerland, UK, Kuwait, Qatar, Turkey, UAE
- Date initiated
- 2023-07-17
- Date posted
- 2024-01-05
- Location
- Ludwigsstadt, Germany
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Aquilex Fluid Control System AQL-100S (K172040) | W.O.M. World of Medicine GmbH | 2018-02-05 |