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Monitoring System Correction: GE HealthCare Updates Use Instructions for Portrait Core Services Software
The U.S. Food and Drug Administration (FDA) is updating the Early Alert “Portrait Core Services Software Issue from GE HealthCare” to inform the public that this issue has been classified as a Class II Recall.
This update also clarifies that the software issue was identified by GE HealthCare during a service update. GE HealthCare has not received any reports of actively monitored patients being removed from monitoring.
The affected products and recommendations for what to do with the devices have not changed.
This recall involves correcting certain devices by removing components affected by another recall. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it without correction.
Questions?
Customers in the U.S. with questions about this recall should contact GE HealthCare at (800) 437-1171.
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