Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1699-2019 — 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.

U.S. FDA — Device Enforcement · United States · 2019-04-03 · Class III

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1699-2019
Date of alert
2019-04-03
Country / jurisdiction
United States
Risk level
Class III
Risk type
recall
Brand
Fresenius Medical Care Renal Therapies Group, LLC
Product category
device
Product type
Devices
Reported risk: Power Logic Board Fail Message on the 2008T BlueStar Machine with software version 2.72.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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