OnSight 3D Extremity System- X-Ray, Tomography Computed System Catalog Numbers: 1743566 (w/ Attached Console) 1743574 (w/ Remote Console) The device is intended to be used for x-ray computed tomography and projection x-ray imaging of upper and lower extremities of adult patients and pediatric patients aged 12 and over.
Class I - DangerousWhat Should You Do?
- Check if you have this product: US Serial Numbers: 58008585 58007506 58000020 58008493 58000015 58007502 58007504 58008494 58007503 58008018 58007505 58008500 58008011 58008014 OUS: 10012 20005 20012 20016 20007 20017 10018 10004 10007 20004 20008 10023 10009 20019 20013 10002 10003 10014 10010 20006 20022 20003 20010
- 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:
- When the user performs the re-assignment of a parent / companion pair, the parent volume is transferred to the new patient but the companion volume will remain in the original patient s exam.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
OnSight 3D Extremity System- X-Ray, Tomography Computed System Catalog Numbers: 1743566 (w/ Attached Console) 1743574 (w/ Remote Console) The device is intended to be used for x-ray computed tomography and projection x-ray imaging of upper and lower extremities of adult patients and pediatric patients aged 12 and over.
Product Codes/Lot Numbers:
US Serial Numbers: 58008585 58007506 58000020 58008493 58000015 58007502 58007504 58008494 58007503 58008018 58007505 58008500 58008011 58008014 OUS: 10012 20005 20012 20016 20007 20017 10018 10004 10007 20004 20008 10023 10009 20019 20013 10002 10003 10014 10010 20006 20022 20003 20010
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1207-2019
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