FDA-Device2014-05-21Class II
Fresenius 2008T Hemodialysis Machine with Revision K Actuator Test Boards and also sold as replacement parts for use with Fresenius 2008-Series Hemodialysis Machines (2008K, 2008K2, 2008K@home and 2008T). Part Number: 190234 Revision K
Fresenius Medical Care Holdings, Inc.
Hazard
2008-Series Hemodialysis Machines with Revision K Actuator Test Boards may fail to detect a disconnected Ultrafiltration (UF) Pump
Sold states
USA (nationwide) and the country of Canada.*
Affected count
79 units
Manufactured in
920 Winter St, Waltham, MA, United States
Products
Fresenius 2008T Hemodialysis Machine with Revision K Actuator Test Boards and also sold as replacement parts for use with Fresenius 2008-Series Hemodialysis Machines (2008K, 2008K2, 2008K@home and 2008T). Part Number: 190234 Revision K
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1618-2014Don't want to check this manually?
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