Liberty Select Cycler Displays Incorrect Timestamp on Treatment Reports
Certain Liberty Select Cycler hemodialysis machines may display an incorrect timestamp on treatment data reports sent to clinics. No injuries or illnesses have been reported.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class III recall with no reported illness or injury. The hazard is an incorrect timestamp on treatment data reports—a functional data quality issue rather than a direct patient safety threat. This falls within the typical range for Class III recalls (score 1-2) and is classified as a minor functional defect affecting data accuracy.
Plain-English summary
Liberty Select Cycler hemodialysis machines (Models RTLR180343 and RTLR180111) manufactured by Fresenius Medical Care Holdings, Inc. are subject to a Class III recall. The affected devices may display an incorrect timestamp on treatment data reports sent to clinics.
Approximately 149 units have been distributed nationwide across Alabama, California, Florida, Illinois, Indiana, Louisiana, Michigan, Missouri, Montana, North Carolina, New Jersey, Nevada, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, and Virginia.
No illnesses or injuries have been reported associated with this recall.
The recalled product
- Product
- Liberty Select Cycler, Model numbers RTLR180343 and RTLR180111
- Manufacturer
- Fresenius Medical Care Holdings, Inc.
- Category
- Medical Device — Hemodialysis
- Affected units
- 149
Distribution
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