GE Healthcare Portrait Core Services SW V 1.2.0, REF 5700592
FDA device recall Z-2878-2026 · posted 2026-08-04 · Open, Classified
Recall details
- Recalling firm
- GE Medical Systems Information Technologies Inc
- Reason for recall
- Portrait Core Services Software version V1.2.0 Security Vulnerability
- Action taken
- 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.
- Root cause
- Software design
- Status
- Open, Classified
- Product code
- MWI
- Quantity affected
- 11 units
- Distribution
- Worldwide - US Nationwide distribution in the state of MI, and the countries of Czech Republic, Finland, Germany, Netherland, Qatar, UAE.
- Date initiated
- 2026-07-10
- Date posted
- 2026-08-04
- Location
- Waukesha, WI
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