Fresenius 2008T Hemodialysis Machine Part Number 190573, 2008T Hemodialysis System, OLCIDIASAFE PLUS Part Number 190713,
FDA device recall Z-1526-2011 · posted 2011-03-04 · Terminated
Recall details
- Recalling firm
- Fresenius Medical Care Holdings, Inc.
- Reason for recall
- Cursor on the dialysis screen may disappear and not respond to user input
- Action taken
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Quantity affected
- 1268 units
- Distribution
- Worldwide Distribution - USA and Canada
- Date initiated
- 2011-01-19
- Date posted
- 2011-03-04
- Date terminated
- 2013-07-08
- Location
- Waltham, MA
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