Elekta Unity Image-Guided Radiation Therapy System containing an MR gradient coil.

Class I - Dangerous

🏥 Medical Devices Recalled: April 6, 2023 Elekta Other Medical Devices Nationwide

What Should You Do?

Check if you have this product:
UDI GTIN 05060191071598, serial numbers: 14117-007/600034, 10632-010/600036, 10817-011/600010, 10905-008/600037, 11198-010/600047, 11198-011/600048, 11830-010/600064, 11888-004/600072, 12108-007/600019, 13371-002/600021, 13553-006/600003, and 30003193-003/600074.
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:: Elekta, Inc.
Reason for Recall:: There is a low possibility that an electrical connector in the MR gradient coil will overheat on Elekta Unity systems.
Classification:: Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
Status:: ongoing

Product Information

Full Description:

Elekta Unity Image-Guided Radiation Therapy System containing an MR gradient coil.

Product Codes/Lot Numbers:

UDI GTIN 05060191071598, serial numbers: 14117-007/600034, 10632-010/600036, 10817-011/600010, 10905-008/600037, 11198-010/600047, 11198-011/600048, 11830-010/600064, 11888-004/600072, 12108-007/600019, 13371-002/600021, 13553-006/600003, and 30003193-003/600074.