FDA Medical Device Recalls (openFDA)
GE Medical Systems, LLC: 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
- Recall number
- Z-0918-2025
- Recalling firm
- GE Medical Systems, LLC
- 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
- Status
- Open, Classified
- Initiated
- 2024-12-06
- Posted
- 2025-01-15
- Terminated
- not on file
- 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.
- Root cause
- Software design
- Action
- 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 FMI.36165@gehealthcare.com. 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.
- Quantity
- 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.
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K234130"]
- PMA numbers
- not on file
- Product code
- MWI
- Firm FEI
- 2126677
- Firm city
- Waukesha
- Firm state
- WI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28