Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 83233

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

Open FDA event record

Event summary

Timeline bucket
June 05, 2019
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
GETINGE US SALES 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

PulsioFlex Monitoring System, Part Number: 6882747, Model Number: PC400 3 R0. Usage: The PulsioFlex Monitoring System is indicated in patients where cardiovascular and circulatory volume status monitoring is necessary. If a patient s biometric data are entered, the PulsioFlex Monitor presents the derived parameters indexed. ¿ -With the PiCCO Module cardiac output is determined both continuously through pulse contour analysis and intermittently through thermodilution technique. Both are used for the determination of other derived parameters. -With the CeVOX oximetry module connected to a compatible oximetry probe, the PulsioFlex Monitoring System measures continuous venous oxygen saturation to assess oxygen delivery and consumption. The use of the PulsioFlex Monitoring System is indicated in patients where cardiovascular and organ monitoring is useful. This includes patients in surgical, medical, and other hospital units

Z-2077-2019
Recall number
Z-2077-2019
Initiated
June 05, 2019
Classification
Class II
Status
Terminated
Recalling firm
GETINGE US SALES LLC
Quantity
7

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The monitor displays an error message . The error message states "internal error restart or service".

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

The monitor displays an error message . The error message states "internal error restart or service".

Code information

software version:V5.1.0.7 US ver. A., Serial number affected: K17400011005 , K17400011065, K17400011082, K17400011086, K17400011097, K17400011107, L17400011267.

Distribution pattern

US Nationwide distribution in the states of MD, OK, NY,FL, SC