FDA Rates GE HealthCare Portrait Monitoring Software Correction a Class II Recall

The FDA has classified GE HealthCare's correction of its Portrait Core Services software, which runs the company's Portrait Mobile patient monitoring system, as a Class II recall, the agency said on Thursday in an update to an early alert it issued in August.

The FDA's updated notice says the agency has determined the device "may cause temporary or reversible health problems, or—though unlikely—serious health problems." The FDA had first flagged the issue as a potentially high-risk device problem in an early alert on August 21. The update also clarified the reason for the recall; the affected products and recommended actions did not change, the notice says. The action is a correction that updates use instructions, and the devices are not being removed from use.

The software problem

According to the notice, GE HealthCare found during a service update of Portrait Core Services software at a facility that some patients monitored on Portrait Mobile devices may be discharged, or removed, from the monitoring system. All alarm settings may also be reset to factory defaults after an update, so the device would not follow alarm settings previously configured for each patient or care area. The FDA notice says the 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," the notice says.

The FDA's recall database lists four entries, Z-3036-2026 through Z-3039-2026, posted August 27, covering software versions 1.0.5, 1.1 and 1.2 and a field-replaceable software reload unit. The entry for version 1.1 lists device design as the FDA-determined cause. The entries list 42 units in commerce in total, distributed in Michigan and New York and in Australia, the Czech Republic, Finland, Germany, Italy, the Netherlands, Qatar, Saudi Arabia, Switzerland, the United Arab Emirates and the United Kingdom.

What GE HealthCare told customers

GE HealthCare sent affected customers a letter on July 20, according to the notice. The company said customers may continue to use Portrait Mobile systems running the affected software, and asked them to:

• Ensure appropriate alternative monitoring is in place for patients before a software update starts.
• Follow a user manual addendum from GE HealthCare with specific instructions on alternative monitoring.
• Keep a copy of the addendum with the system's user manual.
• Make all potential users in the facility aware of the issue.

The FDA notice describes the Portrait Mobile Monitoring Solution as intended to acquire, store, calculate, display and export patient monitoring data and provide real-time alarms for adult and pediatric patients. The database lists the software under product code MWI for physiological patient monitors. Customers with questions can contact GE HealthCare at (800) 437-1171, the notice says.