GE OEC 8800 Flexview X-ray System Recalled for Safety Issues
GE OEC Medical Systems is recalling OEC 8800 Flexview x-ray systems due to intermittent safety issues including navigation tracking inaccuracy and system lock-up.
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 with potential safety issues such as system lock-up and incorrect image display, which pose a risk of harm to patients, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
GE OEC Medical Systems, Inc. is recalling the OEC 8800 Flexview, an image-intensified fluoroscopic x-ray system. The recall involves 1,257 units, including 472 domestic systems, distributed worldwide and across the United States.
The recall was initiated due to several intermittent potential safety issues. These issues include navigation tracking inaccuracy, system lock-up, incorrect image display, and incorrect dose area calculated air kerma in film mode. The source notes that the firm took action in November 2006, but the recall is now being classified by the Agency due to administrative issues.
The OEC 8800 Flexview is designed to provide fluoroscopic and spot-film imaging during diagnostic, surgical, and interventional procedures. Clinical applications may include cholangiography, urologic, endoscopic, orthopedic, neurologic, vascular, cardiac, critical care, and emergency room procedures. Users should contact GE OEC Medical Systems for further instructions on the recall.
The recalled product
- Product
- OEC 8800 Flexview, 892.1650 Image-intensified fluoroscopic x-ray system Product Usage: The 8800 Flexview is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical, and interventional procedures. Clinical applications may include c
- Manufacturer
- GE OEC Medical Systems, Inc
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)
- 2791PU2
- 2792PU0
- 2793PU8
- 2795PU3
- 2797PU9
- 2799PU5
- 2800PU1
- 2801PU9
- 2802PU7
- 2803PU5
- 2805PU0
- 2806PU8
- 2807PU7
- 2808PU4
- 2831PU6
- 2832PU4
- 2834PU0
- 2835PU7
- 2895PU1
- 2897PU7
Distribution
Distributed nationwide across the United States.
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 · system lockup
See all →- HighPhilips Affiniti Ultrasound Systems Recalled for Software Lock-Up During Exams
FDA (Devices) · 2021-09-29
- HighSiemens Sensis Vibe Systems Recalled for Potential System Freezes
FDA (Devices) · 2021-03-10
- HighPhilips Velara Generator Recall for System Lockup Risk
FDA (Devices) · 2017-02-01
- HighPhilips Recalls Velara Generators Due to Potential System Lockup
FDA (Devices) · 2017-02-01
- ModerateSiemens ACUSON X700 Ultrasound System Recalled for Software Lockup
FDA (Devices) · 2016-05-04