Fresenius 2008T Hemodialysis Machine Part Number 190573, 2008T Hemodialysis System, OLCIDIASAFE PLUS Part Number 190713, 2008T Hemodialysis System with CDX Part Number 190766, 2008T Hemodialysis System with biBag The Fresenius 2008T is indicated for acute and chronic dialysis therapy.
Recall
- Recall Number
- Z-1526-2011
- Event Number
- 57851
- Firm
- Fresenius Medical Care Holdings, Inc.
- FEI Number
- 3001451489
- Status
- Terminated
- Root Cause
- Device Design
- Initiated
- January 19, 2011
- Posted
- March 4, 2011
- Terminated
- July 8, 2013
- Address
- 920 Winter St, Waltham, MA, 02451-1521
Description
Fresenius 2008T Hemodialysis Machine Part Number 190573, 2008T Hemodialysis System, OLCIDIASAFE PLUS Part Number 190713, 2008T Hemodialysis System with CDX Part Number 190766, 2008T Hemodialysis System with biBag The Fresenius 2008T is indicated for acute and chronic dialysis therapy.
Cursor on the dialysis screen may disappear and not respond to user input
Fresenius Medical Care contacted customers by mailing a Customer Notification letter "Urgent correction FMNCA Model 2008T Hemodialysis Machine" via Certified-Mail, Return Receipt requested on January 19, 2011. The Technical Services department began contacting consignees by telephone on January 13, 2011, to schedule an appointment for installing the electronic board on the 2008T machines at the customers' facilities. For questions call Technical services 1-800-227-2572.
Worldwide Distribution - USA and Canada
1268 units