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.
FDA Recall Z-1699-2019 · Posted None
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Recalling FirmFresenius Medical Care Renal Therapies Group, LLC
Recall StatusTerminated
Product CodeKDI
Date Initiated2019-04-03
Date Terminated2019-08-30
Product Quantity257 units
Reason for Recall
Power Logic Board Fail Message on the 2008T BlueStar Machine with software version 2.72.
Firm Action
Fresenius issued An IMPORTANT MEDICAL DEVICE CORRECTION notification explains the problem, health risk and that a Fresenius Service Technician (FST) will be contacting them to schedule the correction.
Questions, please contact Fresenius Technical Services at 800-227-2572.
Root Cause
Nonconforming Material/Component
Distribution Pattern
US Nationwide distribution.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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