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Recall Observatory FDA recall evidence

Device 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.

Z-1699-2019

April 03, 2019

Class III

Product summary

Firm
Fresenius Medical Care Renal Therapies Group, LLC
Event
Event 82729
Status
Terminated
Classification
Class III
Quantity
257 units
Official record key
device-enforcement:Z-1699-2019

Official wording

Reason: Power Logic Board Fail Message on the 2008T BlueStar Machine with software version 2.72.

Code information: Software v.2.72

Distribution pattern: US Nationwide distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Power Logic Board Fail Message on the 2008T BlueStar Machine with software version 2.72.