Class 2 Device Recall GE Healthcare Portrait Core

• Date Initiated by Firm: July 10, 2026
• Date Posted: August 04, 2026
• Recall Status: Open, Classified
• Recall Number: Z-2878-2026
• Recall Event ID: 99475
• 510(K)Number: K234130
• Product Classification: Monitor, physiological, patient (without arrhythmia detection or alarms) - Product Code MWI
• Product: GE Healthcare Portrait Core Services SW V 1.2.0, REF 5700592
• Code Information: GTIN 00198953056752, Lot/Serial Numbers: SWT25510001TA, 3M1D391215, 3M1D411081, 3M1D411083, 3M1D3B100D, SWT26110010TA, SWT26070001TA, SWT26120008TA, 3M1D411080, 3M1D411082, 3M1D3B100C.
• FEI Number: 3001570235
• Recalling Firm/ Manufacturer: GE Medical Systems Information Technologies Inc; 3114 N Grandview Blvd; Waukesha WI 53188-1615
• For Additional Information Contact: GE HealthCare Service; 800-437-1171
• Manufacturer Reason for Recall: Portrait Core Services Software version V1.2.0 Security Vulnerability
• FDA Determined Cause: Software design
• Action: GE Healthcare issued an URGENT MEDICAL DEVICE CORRECTION to its consignees on 7/10/2026 via traceable means. The notice explained the safety issue, and requested the following: "Actions to be taken by Customer/User You can continue to use Portrait Mobile Monitoring Solution with Portrait Core Services SW V1.2.0, pending GE HealthCare correction. If you need help to identify if your Portrait Mobile Monitoring Solution has Portrait Core Services SW 1.2.0, contact GE HealthCare Service. Ensure that your facility follows all hospital networking and cybersecurity policies and procedures along with the security considerations outlined in the GE HealthCare Portrait Mobile Monitoring Solution Privacy and Security Manual p/n 5970026. 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 a local Service Representative.
• Quantity in Commerce: 11 units
• Distribution: Worldwide - US Nationwide distribution in the state of MI, and the countries of Czech Republic, Finland, Germany, Netherland, Qatar, UAE.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = MWI