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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 96027

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

Open FDA event record

Event summary

Timeline bucket
December 06, 2024
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
GE Medical Systems, 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

Portrait Core Services, a set of software services that enable the communication and interaction of the Portrait Mobile Monitoring Solution components and will integrate into existing healthcare facility infrastructure and clinical information systems, Model CSSXB

Z-0918-2025
Recall number
Z-0918-2025
Initiated
December 06, 2024
Classification
Class II
Status
Ongoing
Recalling firm
GE Medical Systems, LLC
Quantity
7 systems

App-derived interpretation

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

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

There is a software issue that can result in the loss of patient monitoring on the Portrait Central Viewer Application after 425 days of continuous run-time.

Code information

UDI-DI: 00195278659446, Serial Numbers: SWT24040001TA SWT24090006TA SWT24150008TA SWT24050001TA SWT24180011TA SWT24180009TA SWT31240012TA SWT24340007TA SWT24360002TA SWT24370001TA SWT24370002TA SWT24180010TA 6399074-7 6399074-8 6399074-9 6399326-1 6399326-2 SWT24060001TA

Distribution pattern

Worldwide - US Nationwide distribution in the states of OH, TX and the countries of Australia, China, Czech Republic, France, Italy, Netherlands, Qatar, Singapore, UAE, UK.