Medical device recalls

Fresenius Medical Care Renal Therapies Group, LLC recalls 2008T BlueStar Machine Software v.2.72-Hemodialysis machine Model Number: 191126 - Product Usage: The 2008T hemodialysi…

Recall date
April 3, 2019
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1699-2019
FDA classification
Class III
Brand / firm
Fresenius Medical Care Renal Therapies Group, LLC
Sold / distributed
US Nationwide distribution.

Why it was recalled

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

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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.

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