PlainRecalls
FDA Devices Moderate Class II Ongoing

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

Reported: January 22, 2025 Initiated: December 6, 2024 #Z-0918-2025

Product Description

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

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.

Details

Recalling Firm
GE Medical Systems, LLC
Units Affected
7 systems
Distribution
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.
Location
Waukesha, WI

Frequently Asked Questions

What product was recalled?
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. Recalled by GE Medical Systems, LLC. Units affected: 7 systems.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on January 22, 2025. Severity: Moderate. Recall number: Z-0918-2025.