GE Healthcare Portrait Core Services SW V 1.2.0, REF 5700592 recallZ-2878-2026 · GE Medical Systems Information Technologies Inc · initiated Jul 10, 2026
Class II Open, Classified All recalls posted in August 2026
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from GE Medical Systems Information Technologies Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Portrait Core Services Software version V1.2.0 Security Vulnerability
FDA root cause category: Software design
What the company is doing
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.
Recall details
- Recall number
- Z-2878-2026
- Recall class
- Class II
- Status
- Open, Classified
- Initiated by the company
- Jul 10, 2026
- Posted by the FDA
- Aug 4, 2026
- Recalling firm
- GE Medical Systems Information Technologies Inc
- Quantity
- 11 units
- Product code
- MWI
- FDA submissions
- K234130
- Distribution
- Worldwide - US Nationwide distribution in the state of MI, and the countries of Czech Republic, Finland, Germany, Netherland, Qatar, UAE.
Product description
GE Healthcare Portrait Core Services SW V 1.2.0, REF 5700592
Code information (models, lots, serial numbers)
GTIN 00198953056752, Lot/Serial Numbers: SWT25510001TA, 3M1D391215, 3M1D411081, 3M1D411083, 3M1D3B100D, SWT26110010TA, SWT26070001TA, SWT26120008TA, 3M1D411080, 3M1D411082, 3M1D3B100C.
Other devices under the same FDA submission
1 device cleared under K234130 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Portrait CSSXBGE Medical Systems Information Technologies, Inc. · TRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGNAL, RADIOFREQUENCY1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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