GE HealthCare OEC 9900 Elite C-arm Systems.
Class I - DangerousWhat Should You Do?
- Check if you have this product: GTIN: 00840682114349
- 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 Medical Systems, LLC
- Reason for Recall:
- GE HealthCare has become aware of a non-conformance to 21 CFR 1020.30 (k) in certain OEC 9800 and OEC 9900 Elite C-arm Systems. Specifically, impacted systems are missing the full layer of lead tape in the collimator covers, which will lead to a small increase in radiation exposure to the patient and/or operator. The missing lead tape is not detectable by the user.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
GE HealthCare OEC 9900 Elite C-arm Systems.
Product Codes/Lot Numbers:
GTIN: 00840682114349
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2342-2025
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