FDA-Device2019-06-12Class III
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.
Fresenius Medical Care Renal Therapies Group, LLC
Hazard
Power Logic Board Fail Message on the 2008T BlueStar Machine with software version 2.72.
Sold states
US Nationwide distribution.
Affected count
257 units
Manufactured in
920 Winter St, Waltham, MA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1699-2019Don't want to check this manually?
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