🔍 RecallPedia

AtomLab 500Plus Dose CalibratorSoftware 2.0.00 through Revision 2.0.08, inclusive Model: 086-332

Class I - Dangerous
🏥 Medical Devices Recalled: August 16, 2021 Biodex Medical Systems Infusion Pumps Nationwide

What Should You Do?

  1. Check if you have this product:
    Serial Number Range:17080651-21061047 UDI: 00718175003329
  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:
Biodex Medical Systems, Inc.
Reason for Recall:
When deleting a previously entered custom isotope, the software deletes the isotope, but not the associated dial setting. Possible other stored custom isotopes may then have incorrect dial settings and may lead to an incorrect dose measurement and/or misadministration
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

AtomLab 500Plus Dose CalibratorSoftware 2.0.00 through Revision 2.0.08, inclusive Model: 086-332

Product Codes/Lot Numbers:

Serial Number Range:17080651-21061047 UDI: 00718175003329

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2581-2021

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