Recall – Hemodialysis machine power logic board fail message

Company: Fresenius Medical Care Renal Therapies Group, LLC
Date of Enforcement Report: 6/12/2019
Class III

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.

Recall Number: Z-1699-2019

REASON

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

RECALLING FIRM/MANUFACTURER

Fresenius Medical Care Renal Therapies Group, LLC on 4/3/2019. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
257 units

DISTRIBUTION

US Nationwide

What’s New

FDA:  Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices

Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:  https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/exemptions-variances-and-alternate-forms-adverse-event-reporting-medical-devices

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.