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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 84142

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

Open FDA event record

Event summary

Timeline bucket
January 28, 2019
Product types
Device
Classifications
Class III
Statuses
Terminated
Recalling firm wording
LivaNova USA 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

LivaNova Sorin Connect DPIII KOMPL. S5 REF 96-415-130, 2017-08-15, IPX1, RXOnly, (01)04033817901594 Product Usage: The S5 System is used to perform, control and monitor extracorporeal blood circulation during an operation for up to six hours.

Z-1119-2020
Recall number
Z-1119-2020
Initiated
January 28, 2019
Classification
Class III
Status
Terminated
Recalling firm
LivaNova USA Inc.
Quantity
5 Datapads

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
Incorrect labeling

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Error in labeling

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Incorrect labeling; it was identified that some Datapad devices contained incorrect labels. Specifically the manufacturing date in the production identifier was incorrect and the manufacturing date on the unique device identifier label was labeled in the format of yy-mm-dd instead of yyyy-mm-dd.

Code information

Device Model, Catalog Number, Serial Number: SORIN CONNECT DPIII KOMPL. S5, 24-90-80, 17BQC0247 SORIN CONNECT DPIII KOMPL. S5, 24-90-80, 17BQC0249 SORIN CONNECT DPIII KOMPL. S5, 24-90-80, 17BQC0250 SORIN CONNECT DPIII KOMPL. S5, 24-90-80, 17BQC0258 DATAPADIII WITHOUT SOFTWARE, 24-90-87, 17BQC0257

Distribution pattern

US: NJ and CA