🔍 RecallPedia

ELEKTA AXESSE, REF XRT 2181, XRT 27891; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

Class I - Dangerous
🏥 Medical Devices Recalled: October 25, 2023 Elekta Other Medical Devices

What Should You Do?

  1. Check if you have this product:
    UDI/DI N/A, Serial Numbers: 152140, 152617, 152691, 152004, 152683, 152994, 153935, 152620, 152809, 152854, 152867, 152885, 152964, 152974, 153192, 153217, 153527, 152499, 153668, 152519, 153118, 153102, 153204, 153166, 152017, 152112, 152325, 152749, 152754, 152755, 152756, 152860, 153006, 151874, 152538, 152839, 152921, 153149, 153267, 152736, 151793, 151802, 151812, 151960, 152600, 152678, 152838
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. 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:
Elekta has identified that if the microswitch within the middle arm is incorrectly setup, there is a potential for an uncontrolled extension of iViewGT / XVI detector arms. When the detector arm is fully deployed there is no risk of uncontrolled extension.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

ELEKTA AXESSE, REF XRT 2181, XRT 27891; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

Product Codes/Lot Numbers:

UDI/DI N/A, Serial Numbers: 152140, 152617, 152691, 152004, 152683, 152994, 153935, 152620, 152809, 152854, 152867, 152885, 152964, 152974, 153192, 153217, 153527, 152499, 153668, 152519, 153118, 153102, 153204, 153166, 152017, 152112, 152325, 152749, 152754, 152755, 152756, 152860, 153006, 151874, 152538, 152839, 152921, 153149, 153267, 152736, 151793, 151802, 151812, 151960, 152600, 152678, 152838

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0447-2024

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