Portrait Core Services, a set of software services that… recallZ-0918-2025 · GE Medical Systems, LLC · initiated Dec 6, 2024
Class II Open, Classified All recalls posted in January 2025
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from GE Medical Systems, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was 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.
FDA root cause category: Software design
What the company is doing
An URGENT MEDICAL DEVICE CORRECTION notification letter dated 12/6/24 was sent to customers. Actions to be taken by Customer/User: You can continue to use your Portrait" Mobile Monitoring Solution v1.1 product, since all potentially impacted systems were recently installed and the safety issue does not manifest until after 425 days of continuous use. Please follow the annual Maintenance Schedule described in Service Manual (PN 5929144) for your Portrait" Mobile to reboot the system. Rebooting the system by following this procedure resets the continuous days of use to zero. Please complete and return the attached Acknowledgement Form to [email protected]. After the Portrait Core Services v1.1 software is updated and corrected by GE HealthCare, please discontinue usage of any Portrait Core Services v1.1 software versions 1.1.0 or 1.1.1 and destroy any software media containing those versions. GE HealthCare will correct all affected products at no cost to you. A GE HealthCare representative will contact you to arrange for the correction. If you have any questions or concerns regarding this notification, please contact GE HealthCare Service at 1-800-437-1171 or your local Service Representative.
Recall details
- Recall number
- Z-0918-2025
- Recall class
- Class II
- Status
- Open, Classified
- Initiated by the company
- Dec 6, 2024
- Posted by the FDA
- Jan 15, 2025
- Recalling firm
- GE Medical Systems, LLC
- Quantity
- 7 systems
- Product code
- MWI
- FDA submissions
- K234130
- 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.
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
Code information (models, lots, serial numbers)
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
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Portrait CSSXBGE Medical Systems Information Technologies, Inc. · TRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGNAL, RADIOFREQUENCY1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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