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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 97934

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

Open FDA event record

Event summary

Timeline bucket
October 25, 2025
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Fresenius Medical Care Holdings, Inc.

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

5008X CAREsystem +CLiC +CDX;

Z-0936-2026
Recall number
Z-0936-2026
Initiated
October 25, 2025
Classification
Class II
Status
Ongoing
Quantity
115 units

App-derived interpretation

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

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Several software anomalies with the potential to impact patient treatment, of which one includes the possibility to result in treatment stop if certain conditions are fulfilled.

Code information

Model Number: M204441; UDI-DI: 00840861102433; All serial numbers produced with a software version prior to 4.82.4;

Distribution pattern

Domestic: LA, MA, MN;

Field note

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