DMLC IV-ERGO - Beam shaping block for Radiation Therapy.

Class I - Dangerous
🏥 Medical Devices Recalled: August 15, 2013 Elekta Infusion Pumps Nationwide

What Should You Do?

  1. Check if you have this product:
    EM-042, EM7-004, EM-046, EM-060, EM-047, EM-029, EM7-003, EM7-002, EM7-008, EM-062, EM-063, EM3-004, 116001, 116012, 116044, 116055, 116014, 116052, 116023, 116056, 116053, 116043, 116047, 116051, 116122, 116068, 116013, 116046
  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:
Clinical mistreatment may occur when there are errors in the clinical workflow, or settings are incorrect.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

DMLC IV-ERGO - Beam shaping block for Radiation Therapy.

Product Codes/Lot Numbers:

EM-042, EM7-004, EM-046, EM-060, EM-047, EM-029, EM7-003, EM7-002, EM7-008, EM-062, EM-063, EM3-004, 116001, 116012, 116044, 116055, 116014, 116052, 116023, 116056, 116053, 116043, 116047, 116051, 116122, 116068, 116013, 116046

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2157-2013

Related Recalls

Due to adapter not being properly aligned or locked in place.

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