Recall Z-2561-2021 ยท HIG Insufflator, Hysteroscopic
WOM World of Medicine AG
Covidien HysteroLux Fluid Management System Control Unit, REF: 72205000
| Date | Jun 18, 2021 |
| Status | Open, Classified |
| Reason | 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 is reached. The outflow measurement will continue, and so the deficit accumulated up to this point will start counting backwards to 0 ml. There is a risk of distention fluid reaching the soft tissue circulatory system. |
| Root cause | Software design |
| Action | On 06/18/21 a recall notice was emailed to their one distributor customer. This customer was informed that a new software version was created that would alert the user when an inflow volume of 28.000 ml is reached. This is designed to prepare the user for manual determination of the deficit. The recalling firm recommends updating the units with the new software version during the next preventive maintenance at the recalling firm's U.S. location with the following contacts to coordinate shipment: Katrin.Glushko@novanta.com, 1-407-438-8810; Robert.Almeida@novanta.com, 1-407-472-1509 |
| Quantity | 1100 |
| Distribution | US Nationwide distribution in the state of CT. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K173489 | GYN-Pump PH304 W.O.M. World of Medicine GmbH, Mar 28, 2018 |