The Recall Desk
SevereFDA (Devices)·Z-1365-2018·Announced 2018-04-18

Fresenius Liberty Select Cycler Recalled for Software Overfill Risk

Fresenius Medical Care is recalling Liberty Select Cyclers due to a software issue that may cause overfill, posing a risk of serious injury or death.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The source text explicitly states that the hazard 'may result in serious injury or death,' which aligns with the rubric criteria for a Severe (4) rating involving significant injury reports or potential for serious harm.

Plain-English summary

Fresenius Medical Care Renal Therapies Group, LLC is recalling 9,293 units of the Liberty Select Cycler (Software v.2.8.7, Material Number RTLR108343). The device is indicated for acute and chronic peritoneal dialysis and was distributed nationwide.

The recall was initiated because the firm identified a software issue related to the Patient Line Check (PLC). This issue may result in an increased risk of Overfill, also known as Increased Intraperitoneal Volume (IIPV). The source text states that Overfill/IIPV may result in serious injury or death.

Patients using the affected devices should contact their healthcare provider or the recalling firm for instructions on how to proceed. The specific serial numbers affected are listed in the official recall documentation.

The recalled product

Product
Liberty Select Cycler (SW v.2.8.7), Material Number RTLR108343 Product Usage: The device is indicated for acute and chronic peritoneal dialysis.
Affected units
9,293

Distribution

Distributed nationwide across the United States.