CS 8100, CATALOG # (s): 5303045, 5311129, 5303060, 5303110 Intended to produce complete or segmented tomographic digital panoramic X-ray images to be used at the direction of healthcare professionals of the dento-maxillo-facial region of the human anatomy as diagnostic support for pediatric and adult patient.
Class I - DangerousWhat Should You Do?
- Check if you have this product: All serial numbers of affected devices.
- 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:
- Carestream Health, Inc.
- Reason for Recall:
- Units device head descended unexpectedly
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
CS 8100, CATALOG # (s): 5303045, 5311129, 5303060, 5303110 Intended to produce complete or segmented tomographic digital panoramic X-ray images to be used at the direction of healthcare professionals of the dento-maxillo-facial region of the human anatomy as diagnostic support for pediatric and adult patient.
Product Codes/Lot Numbers:
All serial numbers of affected devices.
Distribution:
Nationwide distribution
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1377-2015
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