GE OEC 6800 Miniview X-ray System Recalled for Safety Issues
GE OEC Medical Systems is recalling 1,933 OEC 6800 Miniview fluoroscopic x-ray systems due to intermittent safety issues, including navigation tracking inaccuracy and system lock-ups.
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 6800 Miniview was recalled in November 2006 due to several intermittent…"
Plain-English summary
GE OEC Medical Systems, Inc. is recalling 1,933 units of the OEC 6800 Miniview, an image-intensified fluoroscopic x-ray system used during diagnostic, surgical, and interventional procedures. The device is designed to provide physicians with general fluoroscopic visualization of patients, including for surgical orthopedic and extremity imaging, but is not intended for whole-body pediatric imaging.
The recall was initiated due to several intermittent potential safety issues, including navigation tracking inaccuracy, system lock-ups, incorrect image display, and incorrect dose area calculated air kerma in "film mode." The source text notes that this is not a new recall; the firm took action in November 2006, but the recall is now being classified by the FDA due to administrative issues.
The affected units were distributed worldwide. The source text does not specify the corrective action taken by the firm or provide specific instructions for consumers or healthcare facilities beyond the recall classification.
The recalled product
- Product
- OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and…
- Manufacturer
- GE OEC Medical Systems, Inc
- Affected units
- 1,933
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)
- 86-1834
- 86-1175
- 86-0238
- 86-0585
- 86-1230
- 86-1992
- 86-0184
- 86-1033
- 86-1480
- 86-1369
- 86-0579
- 86-1678
- 86-1059
- 86-0639
- 86-0389 & 86-0390
- 86-0775
- 86-0850 & 86-1703
- 86-0151 & 86-1311
- 86-1883
- 86-0048 & 86-2015
Distribution
Distribution scope not specified by the agency.
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