FDA recall, , Moderate risk
GE Healthcare Portrait Core Services Software
GE Healthcare Portrait Core Services SW V 1.2.0 patient monitoring system has a software vulnerability that may allow unauthorized access.
Summary by Recall Canary from the FDA notice
What happened
GE Medical Systems Information Technologies Inc, of Waukesha, Wisconsin, recalled its GE Healthcare Portrait Core Services SW V 1.2.0, REF 5700592 patient monitoring system because a software vulnerability may allow unauthorized persons to gain privileged access to the device.
This could result in loss of patient monitoring, missed patient alarms, and/or access to Protected Health Information (PHI). The company began the recall on July 10, 2026, and it was added to the FDA's Enforcement Report on August 4, 2026.
The recall involves 11 units distributed worldwide, including the state of Michigan in the US and the countries of Czech Republic, Finland, Germany, Netherland, Qatar, and UAE.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Affected if its UDI-DI matches.
A UDI-DI is the device identifier printed with the barcode on the device label.
GE Healthcare Portrait Core Services SW V 1.2.0, REF 5700592. patient monitoring system
- UDI-DI
- 00198953056752
Recall details
- Company began the recall
- Sold in
Worldwide - US Nationwide distribution in the state of Michigan, and the countries of Czech Republic, Finland, Germany, Netherland, Qatar, UAE.
- Company
- GE Medical Systems Information Technologies IncWaukesha, Wisconsin
- Hazard
- Software defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99475
- Recall number
- Z-2878-2026
- Quantity recalled
- 11 units
All recalls from GE Medical Systems Information Technologies Inc
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated