The agency also clarified its description of the Portrait Core Services software issue, which can result in patients being removed from monitoring or alarm settings resetting during software updates.
The US Food and Drug Administration has classified a software correction initiated by GE HealthCare for its Portrait Mobile Monitoring Solution as a Class II recall, according to an agency notice. The recall involves updated instructions for use rather than the physical removal of devices from healthcare facilities.
The FDA’s updated communication also clarifies the reason for the recall following an earlier alert about the software issue. The affected products and recommendations for healthcare facilities have not changed, according to the agency.
The correction affects Portrait Core Services software versions 1.0.5, 1.1, and 1.2, along with Portrait Core Services software reload V1.1. The FDA determined that the affected devices may cause temporary or reversible health problems or, though unlikely, serious health problems.
Software Servicing Risks and Alarm Resets
GE HealthCare identified during a service update at a facility that some patients monitored on Portrait Mobile devices may be discharged, or removed, from the Portrait monitoring system, according to the FDA. GE HealthCare says it has not received reports of actively monitored patients being removed from monitoring.
In addition, all alarm settings may reset to factory defaults following an update. If this occurs, the device will not follow the alarm settings previously configured for individual patients or care areas, which can result in a loss of patient monitoring or intended alarms at the Hub and Central Viewer.
As of July 29, GE HealthCare had not reported any serious injuries or deaths associated with the issue, according to the FDA.
“Patient safety is our top priority. We are notifying customers to establish alternate patient monitoring before beginning a software update. There have been no injuries reported to GE HealthCare as a result of this issue,” a GE HealthCare spokesperson said in a statement provided to 24×7.
Recommended Actions for Healthcare Facilities
The Portrait Mobile Monitoring Solution is designed to acquire, store, calculate, display, and export patient monitoring data and provide real-time alarms for adult and pediatric patients, according to the FDA.
On July 20, GE HealthCare sent a letter to affected customers outlining recommended actions. The company advised that healthcare facilities may continue using Portrait Mobile Monitoring Solution devices operating on Portrait Core Services software versions 1.0.5, 1.1, or 1.2, provided appropriate alternative monitoring is established for patients before beginning a software update.
Healthcare technology management teams and clinical users are advised to:
- Establish appropriate alternative patient monitoring before initiating a software update.
- Review 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 affected Portrait Mobile Monitoring systems.
- Ensure all potential users at the facility are aware of the issue and recommended actions.
US customers with adverse reactions, quality problems, or questions about the issue can contact GE HealthCare, according to the FDA.
