Monitoring System Correction: GE HealthCare Updates Use Instructions for Portrait Core Services Software

This is an update to an Early Alert. The FDA has since determined that this device may cause temporary or reversible health problems, or—though unlikely—serious health problems. This recall involves updating instructions for using devices, and does not involve removing them from where they are used or sold. The reason for recall has been updated for clarity; the affected products and recommendations for what to do with the devices below have not changed. 

Affected Product

The FDA is aware that GE HealthCare has issued a letter alerting affected customers of updated use instructions for Portrait Mobile Monitoring Solutions devices operating on certain versions of Portrait Core Services software. Affected devices:

What to Do

Ensure appropriate alternative monitoring is established for patients before starting a software update. Portrait Mobile Monitoring Solution devices with affected Portrait Core Services software may continue to be used.  

On July 20, GE HealthCare sent all affected customers a letter recommending the following actions:

• You may continue to use your Portrait Mobile Monitoring Solution with Portrait Core Services software V1.0.5, V1.1 or V1.2.  
• Ensure appropriate alternative monitoring is established for patients before a software update is started.  
• Refer to the User Manual addendum provided by GE Healthcare for specific instructions related to alternative monitoring.  
• Place a copy of the addendum with the User Manual for your Portrait Mobile Monitoring Solution with Portrait Core Services SW V1.0.5, V1.1 or V1.2 system in your facility.  
• Ensure all potential users in your facility are made aware of this issue and the recommended actions.  

Reason for Correction

GE HealthCare identified during a service update of Portrait Core Services software at a facility that some patients monitored on Portrait Mobile devices may be discharged (removed) from the Portrait monitoring system. 

In addition, all alarm settings may be reset to factory defaults following the updates. In this event, the device will not follow the alarm settings previously configured for each patient or care area.  

This condition can result in a loss of patient monitoring or the intended alarms at the Hub and Central Viewer.  

As of July 29, GE HealthCare has not reported any serious injuries or deaths associated with this issue.

Device Use

The Portrait Mobile Monitoring Solution is intended to acquire, store, calculate, display and export patient monitoring data as well as provide real time alarming for monitoring adult and pediatric patients.

Contact Information

Customers in the U.S. with adverse reactions, quality problems, or questions about this issue should contact GE HealthCare at (800) 437-1171.

Additional FDA Resources  

1. FDA Enforcement Report
2. CDRH Medical Device Recall Database

Unique Device Identifier (UDI)

The unique device identifier (UDI) helps identify individual medical devices sold in the United States from distribution to use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified more quickly, and as a result, problems potentially resolved more quickly.

• How do I recognize a UDI on a label? 
• AccessGUDID database - Identify Your Medical Device 
• Benefits of a UDI System

How do I report a problem?

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.

Timeline of Communication Updates