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Terminated

2008T, Hemodialysis Delivery System Product Indicated for acute and chronic dialysis therapy.

FDA Recall Z-0829-2018 · Posted 2018-02-20

Recalling FirmFresenius Medical Care Renal Therapies Group, LLC
Recall StatusTerminated
Product CodeKDI
Date Initiated2017-10-05
Date Terminated2021-07-28
Product Quantity15 machines

Reason for Recall

While reviewing documentation for the next software release of the 2008T, an R&D technician identified that setting the UF goal to '0' introduces a discrepancy between the UF rate displayed and the actual UF pump rate. The software anomaly is also applicable to the 2008T Machines that contained the 2.63 Bug Fix per DCAF 17-088. 2008T Upgrade kits that contained the 2.63 Bug Fix are also affected. Additionally, SW version 2.64 (in design freeze) is also impacted by this anomaly.

Firm Action

Fresenius Medical Care sent an Urgent Medical Device Correction letter dated April 24, 2017 to affected customers. the letter identified the affected product, problem and actions to be taken. For questions contact Technical Services at 1-800-227-2572.

Root Cause

Software Design Change

Distribution Pattern

US Nationwide Distribution

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K121341FRESENIUS 2008T HEMODIALYSIS MACHINE WITH BIBAG SYSTEMFresenius Medical Care North America · 2012-12-06K120505FRESENIUS 2008T HEMODIALYSIS MACHINEFresenius Medical Care North America, Design Cente · 2012-03-06K120017FRESENIUS 2008 HEMODIAYSIS MACHINE WITH BIBAG SYSTEMFresenius Medical Care North America · 2012-02-02K113427FRESENIUS 2008T HEMODIALYSIS MACHINEFresenius Medical Care North America · 2011-12-21K080964FRESENIUS MODEL 2008T HEMODIALYSIS MACHINEFresenius Medical Care North America · 2009-01-14

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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