Forte Gamma Camera System is intended to produce images depicting the anatomical distribution of single-photon and positron-emitting radioisotopes within the body for interpretation by medical personnel.
Class I - DangerousWhat Should You Do?
- Check if you have this product: System Code: 882320 and 882321 All systems.
- 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:
- An issue with the Detector for the Forte Family of cameras may result in either detector 1 or detector 2 falling unimpeded vertically to the end stops of its travel limit.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Forte Gamma Camera System is intended to produce images depicting the anatomical distribution of single-photon and positron-emitting radioisotopes within the body for interpretation by medical personnel.
Product Codes/Lot Numbers:
System Code: 882320 and 882321 All systems.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0215-2020
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