MHI-TM2000 Linear Accelerator System Product Usage: MHI-TM2000 Linear Accelerator System is intended for radiation therapy of lesions, tumors and conditions anywhere in the body where radiation treatment is indicated.
Class I - Dangerous 🏥 Medical Devices
Recalled: December 8, 2017 Hitachi Ltd., Medical System Operations Group Other Medical Devices
What Should You Do?
- Check if you have this product: Serial Number: 203919
- 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 Ltd., Medical System Operations Group
- Reason for Recall:
- Due to a system controller software anomaly, the patient positioning deviation correction may not be applied and may result in the wrong part of the patient being irradiated.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
MHI-TM2000 Linear Accelerator System Product Usage: MHI-TM2000 Linear Accelerator System is intended for radiation therapy of lesions, tumors and conditions anywhere in the body where radiation treatment is indicated.
Product Codes/Lot Numbers:
Serial Number: 203919
Distribution:
Distributed in: US, NY
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1585-2018