GE HealthCare updates use instructions for Portrait Mobile monitoring software after FDA safety alert
GE HealthCare has sent a letter to customers using its Portrait Mobile Monitoring Solution devices, advising updated instructions for certain versions of the Portrait Core Services software.
The FDA has classified the issue as a potential safety concern, noting that the devices could cause temporary or reversible health problems, though serious effects are unlikely.
The recall does not require removal of the devices; instead, users should ensure alternative monitoring is in place before applying software updates and may continue using versions V1.0.5, V1.1, or V1.2.
The affected software versions are listed in the notice, and GE HealthCare recommends confirming appropriate monitoring during the update process.
This writeup was produced by pharmadog from original reporting by fda medwatch.
Original headline: “Monitoring System Correction: GE HealthCare Updates Use Instructions for Portrait Core Services Software”
read at fda medwatch ↗
comments(0)
5-min edit window · permanent after that