🔍 RecallPedia

Integra XKnife¿ Stereotactic Radiosurgery and Radiotherapy Treatment Planning, Software Versions 5.0.1 and 5.0.2. Intended for use in stereotactic and non-stereotactic (frameless stereotactic), collimated beam, computer planned, linear accelerator (Linac) based treatment.

Class I - Dangerous
🏥 Medical Devices Recalled: December 10, 2012 Integra LifeSciences Other Medical Devices

What Should You Do?

  1. Check if you have this product:
    Software Versions 5.0.1 and 5.0.2.
  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:
Integra LifeSciences Corp.
Reason for Recall:
Depending on the system configuration, a software error message in versions 5.0.1 and 5.0.2. occurs if a beam plan is transmitted from XKnife using DICOM-RT.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Integra XKnife¿ Stereotactic Radiosurgery and Radiotherapy Treatment Planning, Software Versions 5.0.1 and 5.0.2. Intended for use in stereotactic and non-stereotactic (frameless stereotactic), collimated beam, computer planned, linear accelerator (Linac) based treatment.

Product Codes/Lot Numbers:

Software Versions 5.0.1 and 5.0.2.

Distribution:

Distributed in: IL, ID, LA, MA, NJ, NY, OH, PA, SD

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1103-2013

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