Fresenius 2008T BlueStar Hemodialysis Machines Recalled for Power Logic Board Fail Message
Fresenius Medical Care is recalling 257 units of the 2008T BlueStar hemodialysis machine due to a power logic board fail message on software version 2.72.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this recall as Class III, which by definition is unlikely to cause adverse health consequences, aligning with the 'Low' severity criteria for documentation or minor issues.
Plain-English summary
Fresenius Medical Care Renal Therapies Group, LLC is recalling 257 units of the 2008T BlueStar hemodialysis machine, model number 191126, equipped with software version 2.72. The recall is due to a power logic board fail message. The affected machines are indicated for acute and chronic dialysis therapy in a healthcare facility.
The recall covers units distributed nationwide in the United States. The U.S. Food and Drug Administration has classified this recall as Class III, indicating that the use of or exposure to the product is not likely to cause adverse health consequences.
Healthcare facilities should contact the recalling firm for instructions on how to address the software issue. Consumers are not directly affected as these devices are used in healthcare settings.
The recalled product
- Product
- 2008T BlueStar Machine Software v.2.72-Hemodialysis machine Model Number: 191126 - Product Usage: The 2008T hemodialysis machine is indicated for acute and chronic dialysis therapy in a healthcare facility.
- Hazard
- Affected units
- 257
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Software v.2.72
Distribution
Distributed nationwide across the United States.
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