FDA Recall
Terminated
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.
Recall: Z-1699-2019
·
Initiated April 3, 2019
Recall
- Recall Number
- Z-1699-2019
- Event Number
- 82729
- Firm
- Fresenius Medical Care Renal Therapies Group, LLC
- FEI Number
- 3001451489
- Product Code
- KDI
- Status
- Terminated
- Root Cause
- Nonconforming Material/Component
- Initiated
- April 3, 2019
- Terminated
- August 30, 2019
- Address
- 920 Winter St, Waltham, MA, 02451-1521
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
Power Logic Board Fail Message on the 2008T BlueStar Machine with software version 2.72.
Action
Fresenius issued An IMPORTANT MEDICAL DEVICE CORRECTION notification explains the problem, health risk and that a Fresenius Service Technician (FST) will be contacting them to schedule the correction. Questions, please contact Fresenius Technical Services at 800-227-2572.
Distribution
US Nationwide distribution.
Quantity
257 units