X80 RADiant Photoelectric Therapy System
Class I - DangerousWhat Should You Do?
- Check if you have this product: Model Number: X80 RADiant Photoelectric Therapy System; Lot Codes: GM0549, GM0567 GM0568, GM0569, GM0570, GM0571 and GM0577; UDI/DI: 5060494200008
- 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:
- Xstrahl Limited
- Reason for Recall:
- There is a potential compatibility issue with the systems and replacement treatment applicators.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
X80 RADiant Photoelectric Therapy System
Product Codes/Lot Numbers:
Model Number: X80 RADiant Photoelectric Therapy System; Lot Codes: GM0549, GM0567 GM0568, GM0569, GM0570, GM0571 and GM0577; UDI/DI: 5060494200008
Distribution:
Distributed in: US, FL, CA, KY
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1404-2022
Related Recalls
Treatment applicator for Gulmay Medical 150 or Xstrahl 150 superficial X-ray therapy system
Xstrahl Limited
Base plate may detach from the main body of the treatment applicator.
If a saved treatment plan with 2 opposing beams is edited prior to approval, then Beam 2 is not updated with the changed parameters upon selecting save, resulting in error messages during the treatment and possible mis-treatment.