🔍 RecallPedia

There is a complaint regarding internal check cable guide mechanism failure for the Nucletron Flexitron brachytherapy afterloader system. Due to an obstruction during the check cable out drive, the internal guiding tube became displaced and the check cable became damaged. This issue could cause treatment interruption or in a very unlikely scenario, incorrect source positioning and radiation treatment errors.

Class I - Dangerous
🏥 Medical Devices Recalled: November 18, 2019 Nucletron BV Infusion Pumps

What Should You Do?

  1. Check if you have this product:
    REF 136149A02; UDI: (01)08717213051126 (11)171127 (21)FT00340 (240)136149
  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:
Nucletron BV
Reason for Recall:
A component failure may lead to treatment interruption or incorrect source positioning.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

There is a complaint regarding internal check cable guide mechanism failure for the Nucletron Flexitron brachytherapy afterloader system. Due to an obstruction during the check cable out drive, the internal guiding tube became displaced and the check cable became damaged. This issue could cause treatment interruption or in a very unlikely scenario, incorrect source positioning and radiation treatment errors.

Product Codes/Lot Numbers:

REF 136149A02; UDI: (01)08717213051126 (11)171127 (21)FT00340 (240)136149

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0772-2020

Related Recalls

Oncentra Brachy 4.5 radiation therapy software The firm name on the label is Nucletron B.V. Oncentra is a radiation therapy planning software designed to analyze and plan radiation treatments in three dimensions for the purpose of treating patients with cancer. The treatment plans provide estimates of dose distributions expected during the proposed treatment and may be used to administer treatments after review and approval by qualified medical personnel.

Nucletron BV

Class I - Dangerous

Incorrect source step size may occur in the software plans

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