Portrait Core Services, a set of software services that enable the communication and interaction of the Portrait Mobile
Summary
The FDA issued a Class II for Portrait Core Services, a set of software services that enable the communication by GE Medical Systems, LLC. 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 ru.
Details
Source
Device Recall
External ID
Z-0918-2025
Action Date
2025-01-22
Status
Ongoing
Category
device
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
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
Quantity Affected: 7 systems
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-12-06
Company
Waukesha, WI
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 249 device recalls issued in the same week, part of 403 device-related FDA actions this month.
GE Medical Systems, LLC has 138 FDA actions in our database, including 121 recalls and 17 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (GE Medical Systems, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does GE Medical Systems, LLC have FDA actions?
GE Medical Systems, LLC has 138 FDA actions in our database, including 121 recalls and 17 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0918-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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