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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Monitoring Devices

Portrait Core Services Software Recalled for Patient Monitoring Loss

Agency Publication Date: January 15, 2025
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Summary

GE Medical Systems, LLC is recalling 7 systems of its Portrait Core Services software (Model CSSXB) due to a software defect that can cause a total loss of patient monitoring. This software integrates mobile monitoring solutions into hospital systems. After 425 days of continuous operation, the Portrait Central Viewer Application may fail to display patient data, preventing medical staff from seeing vital signs. No injuries or incidents have been reported to date, and the manufacturer has notified affected facilities by letter.

Risk

If the software fails after its run-time limit, clinicians may lose the ability to monitor patient vital signs through the central application. This lack of oversight could lead to a delay in recognizing life-threatening changes in a patient's condition, potentially resulting in serious injury or death.

What You Should Do

  1. This recall affects Portrait Core Services (Model CSSXB), a set of software services used to manage communication for the Portrait Mobile Monitoring Solution in healthcare facilities.
  2. Identify affected systems by checking the Unique Device Identifier (UDI-DI) 00195278659446 and the system serial numbers. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.
  4. For additional questions, call the FDA at 1-888-463-6332 (1-888-INFO-FDA).

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Portrait Core Services (Model CSSXB)
Model / REF:
CSSXB
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
UDI:
00195278659446

A software issue can result in loss of patient monitoring on the Portrait Central Viewer Application after 425 days of continuous run-time.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96027
Status: Active
Manufacturer: GE Medical Systems, LLC
Sold By: GE Medical Systems authorized channels; Healthcare facilities
Manufactured In: United States
Units Affected: 7 systems
Distributed To: Ohio, Texas

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.