Fresenius Liberty Select Cycler Software Recall for Inadequate Dialysis Risk
Fresenius Medical Care is recalling Liberty Select Cycler devices with software version 2.9.0 because a software error may cause the device to fail to recognize extra fluid, potentially leading to inadequate dialysis.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product where the defect could lead to inadequate dialysis and toxin accumulation, but the source text does not report any specific injuries or illnesses, fitting the criteria for a High severity score.
Plain-English summary
Fresenius Medical Care Holdings, Inc. is recalling 9,907 Liberty Select Cycler devices (Model Numbers 180343 and RTLR180343) equipped with Software Version 2.9.0. The recall is due to a software defect that may cause the device to detect an incorrect Heater Bag volume. This error can trigger a 'Supply Bag Line Blocked' alarm, causing the Heater Bag to contain more fluid than expected. The cycler does not recognize this extra fluid and will not make it available for treatment, which may result in insufficient solution to complete the dialysis session.
Inadequate dialysis can lead to the accumulation of toxins and fluid in the body. Symptoms associated with this condition may include shortness of breath, increased weight gain, and increased blood pressure. The affected devices were distributed nationwide throughout the U.S. and Puerto Rico. Of the 9,907 devices currently in the field, 361 have been deactivated, and 4,870 are ready to be shipped to customers along with an Urgent Medical Device Correction notice and response form.
Patients using these devices should contact their healthcare provider or Fresenius Medical Care for instructions on how to proceed with treatment and to receive the necessary software correction.
The recalled product
- Product
- Liberty Select Cycler Software Version 2.9.0 Model Number 180343 and RTLR180343
- Manufacturer
- Fresenius Medical Care Holdings, Inc.
- Affected units
- 9,907
Distribution
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