FDA recall Z-1699-2019

Fresenius Medical Care Renal Therapies Group, LLC · Class III · 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.

Reason for recall

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

Distribution

US Nationwide distribution.

Key facts

Status: Terminated
Initiation date: 2019-04-03
Report date: 2019-06-12
Termination date: 2019-08-30
Voluntary/Mandated: Voluntary: Firm initiated
Location: Waltham, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1699-2019