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.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Please be aware that this is not a new recall. The firm has taken action; but, due to administrative issues this recall is now being classified by the Agency. The OEC 8800 Flexview was recalled in November 2006 due to several intermittent…"
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…
- 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.
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