FDA-Device2025-01-22Class II
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
Hazard
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.
Sold states
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.
Affected count
7 systems
Manufactured in
3000 N Grandview Blvd, Waukesha, WI, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0918-2025More GE Medical Systems, LLC recalls
- FDA-Device2026-06-17GE HealthCare Allia IGS 3 Pulse angiographic X-ray system recalled for electrical shock risk to service personnel
- FDA-Device2026-06-17GE Allia IGS Pulse X-ray system recalled for electrical shock risk to service personnel
- FDA-Device2026-06-17GE HealthCare Allia Moveo X-ray system recalled for electrical shock risk to service personnel
- FDA-Device2026-06-17GE Allia IGS 5 Pulse angiographic X-ray system recalled for electrical shock risk to service personnel
- FDA-Device2026-06-17GE Allia IGS 7 Pulse X-ray system recalled for electrical shock risk to service personnel
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