GE Healthcare Recalls Carescape Patient Data Module Software
GE Healthcare is recalling Carescape Patient Data Module units with v2.0 software due to two issues that may impact patient care.
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: The recall involves a medical device where the software issues 'may impact patient care,' representing a risk-of-harm product where specific injury has not yet been reported, consistent with the High severity criteria.
Plain-English summary
GE Healthcare, LLC is recalling approximately 10,250 units of the Carescape Patient Data Module (PDM) equipped with Version 2.0 software. The PDM is intended to provide physiologic parameter data for adult, pediatric, and neonatal patients during bedside and transport care episodes. The affected modules are used with Solar 8000M/l, Transport Pro, or Carescape B650/B850 host monitors.
The recall was initiated because GE Healthcare became aware of two issues with the Version 2.0 software that may impact patient care. The source text does not specify the nature of these issues or report any specific injuries or illnesses.
The affected units were distributed worldwide, including in the United States and numerous international countries. Healthcare facilities should contact GE Healthcare for further instructions on how to address the software issues.
The recalled product
- Product
- GE Healthcare Carescape Patient Data Module with v2.0 software used with Solar 8000M/l, Transport Pro or Carescape B650/B850 host monitor. The Patient Data Module (PDM) is intended to provide physiologic parameter data on adult, pediatric and neonatal patients during bedside and
- Manufacturer
- GE Healthcare, LLC
- Category
- Medical Device — Patient Monitor
- Affected units
- 10,250
Distribution
Related recalls
Same manufacturer · GE Healthcare, LLC
See all →- HighGE SIGNA Premier MRI magnets may have ferrous fittings fitted
FDA (Devices) · 2026-04-08
- HighGE Medical Imaging Software: Inaccurate Measurements in Global Stack Viewport
FDA (Devices) · 2022-08-31
- HighGE Healthcare CT, PET, and NM Patient Tables May Drop During Service
FDA (Devices) · 2022-08-17
- HighGE Centricity PACS Software fails to notify of exam study modifications
FDA (Devices) · 2022-08-03
- HighSIGNA Premier MRI scanner recalled for elevated acoustic noise hazard
FDA (Devices) · 2022-07-27
Same hazard · software defect
See all →- HighMidmark IQecg Digital ECG Software Recall for Inaccurate Waveforms
FDA (Devices) · 2026-09-02
- HighMidmark Digital ECG Software Recall for Incorrect Waveform Display
FDA (Devices) · 2026-09-02
- ModerateEndoFLIP System Recall Due to Incorrect Catheter Expiration Flags
FDA (Devices) · 2026-08-26
- HighBeckman Coulter DxC 500i Analyzer Modules Recalled for Software Defect
FDA (Devices) · 2026-08-26
- HighMitsubishi Recalls Outlander Models for Rearview Camera Software Defect
NHTSA · 2026-08-25