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
- Company
- Ge Medical Systems, Llc
- Recall Initiated
- December 6, 2024
- Posted
- January 15, 2025
- Recall Number
- Z-0918-2025
- Quantity
- 7 systems
- Firm Location
- Waukesha, WI
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.
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 / Code Info
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
Root Cause
Software design
Action Taken
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.