The US Food and Drug Administration keeps a page of medical device recalls and early alerts. On August 21, 2026 it issued an early alert on GE HealthCare's Portrait Mobile Monitoring Solution, and on September 3 it updated it to clarify the reason and to say the issue had been classified as a Class II recall. The FDA says it has determined that the device "may cause temporary or reversible health problems," or, "though unlikely," serious ones. The system, the page says, 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." Parts of the page follow, not the whole.
During a Service Update
The alert covers devices operating on certain versions of the system's Portrait Core Services software. "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," the FDA says. "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, the page says, GE HealthCare "has not reported any serious injuries or deaths associated with this issue."
What Facilities Are Told
"This recall involves updating instructions for using devices, and does not involve removing them from where they are used or sold," the FDA says.
On July 20, GE HealthCare sent affected customers a letter. The devices "may continue to be used," the FDA says. The letter's recommendations include that facilities "Ensure appropriate alternative monitoring is established for patients before a software update is started," and refer to the user manual addendum GE HealthCare provided for instructions on alternative monitoring.
The update is where the risk sits, and the instruction is to watch the patients another way while it runs. The page does not say how a facility would confirm, once the update is done, that every patient is back on the system and every alarm is set as it was before.
After a software update on a system that watches patients, what would tell the staff that it is watching all of them, with the alarms they set?
Sources
- U.S. Food and Drug Administration. Monitoring System Correction: GE HealthCare Updates Use Instructions for Portrait Core Services Software (Medical Device Recalls and Early Alerts). 21 August 2026 (updated 3 September 2026). safety notice