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Aquilex® Fluid Control System
W.O.M. World of Medicine GmbH · Model AQL-100P · UDI-DI 04056702002121
10
510(k) clearances
541
Adverse events (12 deaths)
6
Recalls
65
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-04-09 | Stryker Corporation | Due to nonconforming products being inadvertently distributed. |
| 2023-07-17 | WOM World Of Medicine AG | 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 coun |
| 2021-06-18 | WOM World of Medicine AG | When the display of inflow volume to the uterus reaches 32450 ml, the fluid management system control unit display will freeze because the internal software calculation threshold i |
| 2019-08-14 | WOM World of Medicine AG | The deficit displayed by the pump can differ from the real deficit, leading potentially to patient risk. |
| 2014-09-01 | Thermedx LLC | To correct software bugs that could affect the ability to accurately measure fluid deficit. |
| 2007-08-17 | Karl Storz Endoscopy America Inc | Outflow Difference: The accuracy of the Equimat displayed value could be influenced by external factors of the cart/stand and may result in a fluctuating or inaccurate reading. |
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