GE Healthcare Wireless Digital Radiography Software Recall for Patient Safety
GE Healthcare is recalling Wireless Digital Radiography Option (WDR1) software due to a defect that may cause patient exams to display incorrectly, potentially impacting patient safety.
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 is classified as FDA Class II, and the source text explicitly states the issue 'may impact patient safety' without reporting specific injuries or deaths, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
GE Healthcare, LLC is recalling the Wireless Digital Radiography Option (WDR1) software used with Precision 500D and Proteus XR/a systems. The recall is due to a software issue associated with patient selection from the worklist that may impact patient safety.
The defect causes patient exams to be displayed improperly on the WDR1 intermittently when a large number of patient exams are retrieved from the HIS/RIS system. This issue affects 359 units, including 333 in the United States and 26 outside the US. The devices are distributed worldwide, including in the US, Argentina, Australia, Canada, France, Ireland, Italy, Jordan, Romania, Russia, the United Arab Emirates, and the United Kingdom.
Healthcare facilities using these systems should contact GE Healthcare for further instructions on how to address the software issue. The recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- GE Healthcare Precision 500D and Proteus XR/a equipped with Wireless Digital Radiography Option (WDR1). The Wireless DR Imaging Option ( WDR1), when used with a radiographic imaging system, is indicted for use in general radiographic images of human anatomy. It is intended for
- Manufacturer
- GE Healthcare, LLC
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