FRU (Field replaceable unit), PORTRAIT CORE SERVICES SW RELOAD V1.1, Ref# 5700225

Software issue may result in a loss of patient monitoring at the Hub and Central Viewer. In addition, all alarm settings could be reset to factory defaults following the update and will not follow the alarm settings previously configured for each patient or care area.

GE Healthcare issued an URGENT MEDICAL DEVICE CORRECTION notice to its consignees on 7/20/2026 by letter delivered using traceable means. The notice explained the issue, potential risk, and requested the following: "Actions to be taken by Customer/User You can continue to use your Portrait Mobile Monitoring Solution with Portrait Core Services SW V1.0.5, V1.1 or V1.2. Please ensure appropriate alternative monitoring is established for patients before a software update is started. A User Manual addendum is included with this letter that includes specific instructions related to alternative monitoring. Please place a copy of the addendum in Appendix A with the User Manual for your Portrait Mobile Monitoring Solution with Portrait Core Services SW V1.0.5, V1.1 or V1.2 system in your facility. Please ensure all potential users in your facility are made aware of this safety notification and the recommended actions. Please retain this document for your records." For questions or concerns regarding this notification, please contact GE HealthCare Service at 1-800-437-1171 or your local Service Representative.