Ingenuity Core Computed Tomography X-ray systems is intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Model #: 728321; Serial #s: 310004, 310005, 310012, 310016, 310020, 310021, 310027, 310028, 310033, 310034, 310041, 310044, 310045, 310057, 310061, 310065, 310072, 310074, 310076, 310077, 310078, 310094, 310099, 310100, 310103, 310105, 310117, 310120, 310135.
- 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:
- Philips Medical Systems (Cleveland) Inc
- Reason for Recall:
- Software defect causing intermittently slow response of Host.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Ingenuity Core Computed Tomography X-ray systems is intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Product Codes/Lot Numbers:
Model #: 728321; Serial #s: 310004, 310005, 310012, 310016, 310020, 310021, 310027, 310028, 310033, 310034, 310041, 310044, 310045, 310057, 310061, 310065, 310072, 310074, 310076, 310077, 310078, 310094, 310099, 310100, 310103, 310105, 310117, 310120, 310135.
Distribution:
Nationwide distribution
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2371-2016
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