PROBEAT-V, software versions 4.8.1S, and 5.1M Radiation therapy system.
Class I - DangerousWhat Should You Do?
- Check if you have this product: 2015B01, A01, A02
- 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:
- Hitachi America, Ltd., Power Systems Division
- Reason for Recall:
- There is a potential for a discrepant target position when using 3D3D matching mode in PIAS (Positioning Image Analysis System) software installed in the PROBEAT-V, proton therapy systems.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
PROBEAT-V, software versions 4.8.1S, and 5.1M Radiation therapy system.
Product Codes/Lot Numbers:
2015B01, A01, A02
Distribution:
Distributed in: AZ, MN, TN
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1892-2019
Related Recalls
PROBEAT WITH DISCRETE SPOT SCANNING SYSTEM Product Usage: Hitachi PROBEAT with DSSS is a medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.
Hitachi America, Ltd., Power Systems Division
At a PROBEAT III site installed in Japan, the operator of the system found that the radiation was delivered inconsistent with the treatment plan and stopped the irradiation. The irradiation control system may be potentially affected when rebooting a part of the control system.