GE Healthcare Definium 8000 Digital Radiographic Systems Recalled for Pinch Hazard
General Electric is recalling 3,796 Definium 8000 Digital Radiographic Systems because an operator's finger was pinched between the fixed roller and the gliding tabletop.
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 risk-of-harm product where a specific injury (pinched finger) has been reported, but the source does not indicate hospitalization or severe injury, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
General Electric Med Systems LLC is recalling 3,796 units of the GE Healthcare Definium 8000 Digital Radiographic Systems, specifically the Revolution XR/d with Tomosynthesis (Model Number 5131070). The recall affects all serial numbers and the products were distributed worldwide.
The recall was initiated after an incident was reported in which an operator's finger was pinched between the fixed roller and the gliding tabletop of a Proteus XR/a Table. The injury occurred while the operator was moving the tabletop with their thumb placed over its edge and fingers underneath.
The Revolution XR/d with Tomosynthesis is intended for generating tomographic images of human anatomy and is not intended for mammographic use. Users should contact General Electric Med Systems LLC for instructions on how to address the pinch hazard.
The recalled product
- Product
- GE Healthcare Definium 8000 Digital Radiographic Systems : GE Healthcare, 3000 North Grandview , Waukesha, WI, 53188 Model Number: 5131070. The Revolution XR/d with Tomosynthesis is intended for use in generating Tomographic images of human anatomy. It is not intended for m
- Manufacturer
- General Electric Med Systems LLC
- Hazard
- Affected units
- 3,796
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)
- All serial numbers
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 3 recalled by General Electric Med Systems LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
Same manufacturer · General Electric Med Systems LLC
See all →- HighGE Proteus XR/a Radiographic System Recalled Due to Pinch Hazard
FDA (Devices) · 2012-06-20
- HighGE Healthcare Revolution XR/d Recalled for Finger Pinch Hazard
FDA (Devices) · 2012-06-20
Same hazard · pinch injury
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NHTSA · 2026-06-09
- High
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