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U.S. Department of Health and Human Services

Class 2 Device Recall Portrait Core Services CSSXB

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 Class 2 Device Recall Portrait Core Services CSSXBsee related information
Date Initiated by FirmDecember 06, 2024
Date PostedJanuary 15, 2025
Recall Status1 Open3, Classified
Recall NumberZ-0918-2025
Recall Event ID 96027
510(K)NumberK234130 
Product Classification Monitor, physiological, patient (without arrhythmia detection or alarms) - Product Code MWI
ProductPortrait 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 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
Recalling Firm/
Manufacturer		 GE Medical Systems, LLC
3000 N Grandview Blvd
Waukesha WI 53188-1615
For Additional Information ContactGE HealthCare Service
800-437-1171
Manufacturer 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.
FDA Determined
Cause 2		Software design
ActionAn 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 in Commerce7 systems
DistributionWorldwide - US Nationwide distribution in the states of OH, TX and the countries of Australia, China, Czech Republic, France, Italy, Netherlands, Qatar, Singapore, UAE, UK.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = MWI
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