FDA-Device2020-11-18Class II
Liberty Select Cycler Software Version 2.9.0 Model Number 180343 and RTLR180343
Fresenius Medical Care Holdings, Inc.
Hazard
The device may detect an incorrect Heater Bag volume which may lead to a 'Supply Bag Line Blocked' alarm during treatment. This alarm may cause the Heater Bag to contain more fluid than expected and the cycler does not recognize the extra fluid is present and it will not make it available for treatment. Not having enough solution to complete treatment may lead to inadequate dialysis which could result in the accumulation of toxins and fluid. Symptoms may include shortness of breath, increased weight gain, and increased blood pressure.
Sold states
Distributed nationwide throughout the U.S and Puerto Rico. 9,907 devices currently in the field. 361 devices have been deactivated. 4,870 devices are ready to be shipped to customers along with the Urgent Medical Device Correction notice and response form.
Affected count
9,907 devices
Manufactured in
920 Winter St Bld 950, Waltham, MA, United States
Products
Liberty Select Cycler Software Version 2.9.0 Model Number 180343 and RTLR180343
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0439-2021Don't want to check this manually?
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