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.
Reported: June 12, 2019 Initiated: April 3, 2019 #Z-1699-2019
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.
Details
- Recalling Firm
- Fresenius Medical Care Renal Therapies Group, LLC
- Units Affected
- 257 units
- Distribution
- US Nationwide distribution.
- Location
- Waltham, MA
Frequently Asked Questions
What product 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.. Recalled by Fresenius Medical Care Renal Therapies Group, LLC. Units affected: 257 units.
Why was this product recalled? ▼
Power Logic Board Fail Message on the 2008T BlueStar Machine with software version 2.72.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 12, 2019. Severity: Low. Recall number: Z-1699-2019.
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