Portrait Core Services Software Loss of Patient Monitoring After 425 Days
A software issue in GE's Portrait Core Services medical device software causes loss of patient monitoring capability in the Portrait Central Viewer Application after 425 days of continuous operation.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall involving a software defect that results in loss of patient monitoring capability. No illnesses or injuries have been reported. The hazard represents a risk-of-harm to patients but without documented incidents, placing it in the High severity category per the rubric.
Plain-English summary
Portrait Core Services is software that enables communication and integration of Portrait Mobile Monitoring Solution components within healthcare facility infrastructure and clinical information systems. A software defect can cause loss of patient monitoring capability in the Portrait Central Viewer Application after 425 days of continuous run-time.
Seven systems are affected and are distributed worldwide, including in the United States (Ohio and Texas), and internationally in Australia, China, Czech Republic, France, Italy, Netherlands, Qatar, Singapore, United Arab Emirates, and United Kingdom.
The affected equipment has been identified by manufacturer GE Medical Systems, LLC with specific serial numbers and identifiers for tracking and follow-up.
The recalled product
- Product
- Portrait Core Services, a set of software services that enable the communication and interaction of the Portrait Mobile Monitoring Solution components and will integrate into existing healthcare facility infrastructure and clinical information systems, Model CSSXB
- Manufacturer
- GE Medical Systems, LLC
- Affected units
- 7
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI-DI: 00195278659446
Distribution
Related recalls
Same manufacturer · GE Medical Systems, LLC
See all →- HighMobile Digital Radiographic System Arm Drop Risk During Patient Exams
FDA (Devices) · 2026-07-22
- HighGE Optima XR200/220/240amx Radiographic System Column Safety Mechanism
FDA (Devices) · 2026-07-22
- HighGE Medical Optima XR200/220/240amx Mobile Radiographic Systems Recall
FDA (Devices) · 2026-07-22
- HighGiraffe OmniBed incubator canopy fasteners can fall into patient compartment
FDA (Devices) · 2026-06-24
- HighGiraffe OmniBed replaceable units share the canopy fastener disengagement defect
FDA (Devices) · 2026-06-24
Same hazard · software defect
See all →- HighMidmark Digital ECG Software Recall for Incorrect Waveform Display
FDA (Devices) · 2026-09-02
- HighMidmark IQecg Digital ECG Software Recall for Inaccurate Waveforms
FDA (Devices) · 2026-09-02
- HighBeckman Coulter DxC 500i Analyzer Modules Recalled for Software Defect
FDA (Devices) · 2026-08-26
- ModerateEndoFLIP System Recall Due to Incorrect Catheter Expiration Flags
FDA (Devices) · 2026-08-26
- HighMitsubishi Recalls Outlander Models for Rearview Camera Software Defect
NHTSA · 2026-08-25