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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 79239

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
October 05, 2017
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Fresenius Medical Care Renal Therapies Group, LLC

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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

Z-0829-2018
Recall number
Z-0829-2018
Initiated
October 05, 2017
Classification
Class II
Status
Terminated
Quantity
15 machines

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
software anomaly

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software Design Change

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

2008T machines: 190766 2008T Hemodialysis System w/Bibag 190895 2008T GEN 2 Bibag without CDX 190766 = 00840861100910 (+Serial Number) 190895 = 00840861100927 (+Serial Number)ux=&Su

Distribution pattern

US Nationwide Distribution