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.
FDA Recall Z-1526-2011 · Posted 2011-03-04
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Recalling FirmFresenius Medical Care Holdings, Inc.
Recall StatusTerminated
Date Initiated2011-01-19
Date Terminated2013-07-08
Product Quantity1268 units
Reason for Recall
Cursor on the dialysis screen may disappear and not respond to user input
Firm Action
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
Distribution Pattern
Worldwide Distribution - USA and Canada
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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