Medical X-Ray System Permits Bypass of Radiation Exposure Control
GE Medical Systems' Discovery XR656HD X-Ray imaging systems can allow radiation exposures to exceed the Automatic Exposure Control limit without blocking further exposure. Approximately 3,149 units are affected worldwide, including 1,697 in the United States.
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 medical device recall involving a defect in a critical safety-control system (Automatic Exposure Control) that allows radiation exposure to exceed intended limits without operator intervention. No injuries or illnesses have been reported. The defect constitutes a risk-of-harm product where injury has not yet been reported, meeting the Score 3 threshold.
Plain-English summary
The Discovery XR656HD X-Ray imaging system, manufactured by GE Medical Systems, LLC, has a defect in its Automatic Exposure Control (AEC) system. The AEC is designed to limit radiation exposure by preventing additional exposures once a safety threshold is reached. However, the system does not actually prevent further exposure.
When the AEC limit is reached, the system displays a message on the screen but does not block the operator from taking additional X-Ray exposures. This means users can inadvertently exceed the intended radiation exposure limits without being forced to acknowledge the limit or adjust their technique.
Approximately 3,149 Discovery XR656HD systems are affected, including 1,697 in the United States and 1,452 distributed internationally to numerous countries. Facilities using affected equipment should refer to the FDA recall notice and contact GE Medical Systems for guidance on addressing this defect.
The recalled product
- Product
- Discovery XR656HD. X-Ray imaging system.
- Manufacturer
- GE Medical Systems, LLC
- Hazard
- radiation-exposure
- exposure-control-defect
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 (2)
- GTINs: 00840682142175
- 00840682142168
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- CriticalMedline spinal anesthetic kits recalled for quality and efficacy concerns
FDA (Devices) · 2026-06-03
- SevereMedline spinal anesthesia kits recalled for bupivacaine quality issues
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Trays Recalled Due to Quality and Efficacy Concerns
FDA (Devices) · 2026-06-03
- HighMedline Medical Convenience Kit Recalled: Wrong Syringe Type Inside
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Block Kits Recalled for Data Integrity and Efficacy Issues
FDA (Devices) · 2026-06-03