FDA Class II Recall of GE HealthCare Patient Monitoring Software
GE Medical Systems Information Technologies recalls 15 units of Portrait Core Services Software V1.0.5 over potential loss of patient monitoring and alarm reset issues.
Every recalls & safety alerts report published for Waukesha, Wisconsin, newest first.
GE Medical Systems Information Technologies recalls 15 units of Portrait Core Services Software V1.0.5 over potential loss of patient monitoring and alarm reset issues.
The FDA has terminated recall Z-3037-2026 for PORTRAIT COMPUTE AND CORE SERVICES V1.2, saying the action is complete.
An FDA enforcement report classes the Class II action, over safety-pawl testing after column replacement on Optima amx systems, as ongoing.