Z-1699-2019 Class III Terminated
Recall Details
- Product Type
- Devices
- Report Date
- June 12, 2019
- Initiation Date
- April 3, 2019
- Termination Date
- August 30, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 257 units
Product Description
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 Pattern
US Nationwide distribution.
Code Information
Software v.2.72