GE OEC Brivo 715 Prime Mobile C-Arm X-Ray Product Used for general surgical applications and musculoskeletal procedures to visualize.
Class I - DangerousWhat Should You Do?
- Check if you have this product: GE OEC Brivo 715 Prime Serial Numbers: B2S1301 6 B2S1301 8 B2S1302 1 B2S13022 B2S13025 B2S13039 B2S13060 B2S13063 B2S13065 B2S14001 B2S14007 B2S14022 B2S14039 B2S1404 0 B2S1404 5 B2S1406 5 B2S1406 6
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- GE OEC Medical Systems, Inc
- Reason for Recall:
- mA Accuracy may exceed the design and labeling specification of+ 10%. Per 1020.32(f): Deviation of x-ray tube potential and current from the indicated values shall not exceed the maximum deviation as stated by the manufacturer in accordance with 1020.30(h)(3).
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
GE OEC Brivo 715 Prime Mobile C-Arm X-Ray Product Used for general surgical applications and musculoskeletal procedures to visualize.
Product Codes/Lot Numbers:
GE OEC Brivo 715 Prime Serial Numbers: B2S1301 6 B2S1301 8 B2S1302 1 B2S13022 B2S13025 B2S13039 B2S13060 B2S13063 B2S13065 B2S14001 B2S14007 B2S14022 B2S14039 B2S1404 0 B2S1404 5 B2S1406 5 B2S1406 6
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0840-2015
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