Monitoring System Correction: GE HealthCare Updates Use Instructions for Portrait Core Services Software

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Center for Devices and Radiological Health - Medical Device Recall

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.

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Questions?

Customers in the U.S. with questions about this recall should contact GE HealthCare at (800) 437-1171.

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