Digital Medical X-ray Imaging System, Model: uDR 596i, uDR 592h
Class I - DangerousWhat Should You Do?
- Check if you have this product: DI/GTIN: 06971576833023, Serial Numbers: 270012, 270013,270014, 270015
- 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:
- Shanghai United Imaging Healthcare Co., Ltd.
- Reason for Recall:
- X-ray imaging system positioning image and protocol label is reversed for Flexion and Extension on C-Spine and L-Spine, this will cause the image to be incorrectly labeled and may cause the patient to have a repeat exposure.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Digital Medical X-ray Imaging System, Model: uDR 596i, uDR 592h
Product Codes/Lot Numbers:
DI/GTIN: 06971576833023, Serial Numbers: 270012, 270013,270014, 270015
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1075-2022
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