FDA-Device2017-01-25Class II
Fresenius 2008T Series Hemodialysis System
Fresenius Medical Care Renal Therapies Group, LLC
Hazard
When the UF Rate, Goal or Time is adjusted using the up and down arrow keys, and the change is cancelled by using the esc key, the cancelled UF Rate is actually being executed rather than rate displayed on the machine
Sold states
Nationwide Foreign: Canada, Mexico, Jamaica, Germany, Guam
Affected count
65361 units (US) 249 units (OUS)
Manufactured in
920 Winter St, Waltham, MA, United States
Products
Fresenius 2008T Series Hemodialysis System
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1026-2017Don't want to check this manually?
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