🔍 RecallPedia

Protura Robotic Couch System Software, versions 1.6.1 (Part Number MT6XSM1.6.1), 1.7.0 (Part Number MT6XSM1.7.0), and 1.7.1 (Part Number MT6XSM1.7.1), CIVCO, Orange City, IA 51041

Class I - Dangerous
🏥 Medical Devices Recalled: March 31, 2016 Med Tec Infusion Pumps

What Should You Do?

  1. Check if you have this product:
    Versions 1.6.1 (Part Number MT6XSM1.6.1), 1.7.0 (Part Number MT6XSM1.7.0), and 1.7.1 (Part Number MT6XSM1.7.1)
  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:
Med Tec Inc
Reason for Recall:
When using the recalled product in split shift mode, the non-sub-millimeter positioning has been found to be inconsistent with the setting parameters.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Protura Robotic Couch System Software, versions 1.6.1 (Part Number MT6XSM1.6.1), 1.7.0 (Part Number MT6XSM1.7.0), and 1.7.1 (Part Number MT6XSM1.7.1), CIVCO, Orange City, IA 51041

Product Codes/Lot Numbers:

Versions 1.6.1 (Part Number MT6XSM1.6.1), 1.7.0 (Part Number MT6XSM1.7.0), and 1.7.1 (Part Number MT6XSM1.7.1)

Distribution:

Distributed in: US

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1992-2016

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