Recall Z-1699-2019— Fresenius Medical Care Renal Therapies Group, LLC
Class III · Terminated
Class III FDA medical device recall by Fresenius Medical Care Renal Therapies Group, LLC, initiated 2019-04-03, terminated 2019-08-30. It names one FDA 510(k) clearance: K173972. 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: Power Logic Board Fail Message on the 2008T BlueStar Machine with software version 2.72..
- Recalling firm
- Fresenius Medical Care Renal Therapies Group, LLC
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2019-04-03
- Terminated
- 2019-08-30
- Firm location
- Waltham, MA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.