GE OEC Brivo Mobile C-Arm X-Ray Recall for Uncontrolled Motion
GE Healthcare is recalling 148 OEC Brivo mobile C-arm X-ray units because a circuit board failure may cause the C-arm to move vertically without command.
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 (uncontrolled movement of heavy medical equipment) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
GE Healthcare Surgery has announced a voluntary field action for the OEC Brivo 715 Prime, OEC Brivo 785 Essential, and OEC Brivo 865 Advance mobile C-arm X-ray products. The recall involves 148 units distributed worldwide, including in specific US states and to foreign consignees. These devices are designed to provide digital spot film imaging and fluoroscopic image guidance for adult and pediatric populations during general surgical and musculoskeletal procedures.
The recall is being issued because the circuit board that controls the vertical motion of the C-arm may fail. This failure can result in the C-arm moving up or down without a command from the operator. The source text does not report any specific injuries or illnesses associated with this defect.
Affected units are identified by specific serial numbers for the OEC715, OEC785, and OEC865 models. Healthcare facilities and users should contact GE OEC Medical Systems, Inc. to arrange for the necessary field action to address the circuit board issue.
The recalled product
- Product
- OEC Brivo 715 Prime, OEC Brivo 785 Essential, OEC Brivo 865 Advance Product Usage: The OEC Brivo Mobile C-Arm X-Ray Products are designed to provide digital spot film imaging and fluoroscopic image guidance for all adult and pediatric populations for orientations between pati
- Manufacturer
- GE OEC Medical Systems, Inc
- Hazard
- Affected units
- 148
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 (20)
- GE Brivo OEC715: Serial Numbers B2S15158 to B2S15164
- B2S15166 to B2S15171
- B2S15173 to B2S15195
- B2S15197
- B2S15200
- B2S15202
- B2S16046
- B2S16050
- B2S16051 GE Brivo OEC785: Serial Numbers B3S15236
- B3S15241
- B3S15242
- B3S15246
- B3S15248
- B3S15250
- B3S15253 to B3S15257
- B3S15259 to B3S15338
- B3S15353
- B3S15357 to B3S15359
- B3S16152 GE Brivo OEC865: Serial Numbers B4S15063 to B4S15070
- B4S15072
Distribution
Related recalls
Same manufacturer · GE OEC Medical Systems, Inc
See all →- HighOEC 9900 Mobile Fluoroscopic X-Ray System Recall for Sealing Defect
FDA (Devices) · 2024-12-25
- HighGE OEC 9800 X-Ray System Recalled for Insufficient Tube Sealing
FDA (Devices) · 2024-12-25
- HighOEC 3D Mobile Fluoroscopic X-Ray System Tube Sealing Defect Recall
FDA (Devices) · 2024-12-25
- HighFluoroscopic X-Ray System Recalled for Insufficient X-Ray Tube Sealing
FDA (Devices) · 2024-12-25
- HighOEC Flexiview 8800 Image Intensifier Risks Detachment During Movement
FDA (Devices) · 2023-08-09
Same hazard · uncontrolled motion
See all →- SevereDa Vinci surgical system operative components with E-brake retainer pin defect
FDA (Devices) · 2026-07-01
- HighVATS lobectomy stapler boxes recalled over a malformed cover tube press
FDA (Devices) · 2025-11-19
- HighSurgical staplers recalled over a malformed cover tube press
FDA (Devices) · 2025-11-19
- HighX-ray C-arm Tabletop Recalled for Risk of Uncontrolled Motion
FDA (Devices) · 2024-05-15
- SevereSenhance Robotic Surgical System uncontrolled arm motion malfunction
FDA (Devices) · 2023-11-08