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Recall Observatory FDA recall evidence

Device product

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

December 06, 2024

Class II

Product summary

Firm
GE Medical Systems, LLC
Event
Event 96027
Status
Ongoing
Classification
Class II
Quantity
7 systems
Official record key
device-enforcement:Z-0918-2025

Official wording

Reason: 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.

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    software issue