🔍 RecallPedia

v.1.2 Upgrade Kit or v.1.2 upgrade installed on WorkMate Claris System, Model H700123. The WorkMate Claris" System is a computer-based electrocardiographic recording and monitoring system designed for efficient capture, display, and retrieval of surface and intracardiac signals during cardiac EP studies.

Class I - Dangerous
🏥 Medical Devices Recalled: May 5, 2021 Abbott Laboratories Inc. (St Jude Medical) Diagnostic Equipment Nationwide

What Should You Do?

  1. Check if you have this product:
    Serial Numbers: 14399319, 15508962, 18782712, 18855856
  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:
Abbott Laboratories Inc. (St Jude Medical)
Reason for Recall:
Due to a software error, the user may lose functionality of the system or the screen may turn black during operation.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

v.1.2 Upgrade Kit or v.1.2 upgrade installed on WorkMate Claris System, Model H700123. The WorkMate Claris" System is a computer-based electrocardiographic recording and monitoring system designed for efficient capture, display, and retrieval of surface and intracardiac signals during cardiac EP studies.

Product Codes/Lot Numbers:

Serial Numbers: 14399319, 15508962, 18782712, 18855856

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1853-2021

Related Recalls

v.1.2 Upgrade Kit or v.1.2 upgrade installed on WorkMate Claris" System Display, Model H700124, The WorkMate Claris" System is a computer-based electrocardiographic recording and monitoring system designed for efficient capture, display, and retrieval of surface and intracardiac signals during cardiac EP studies.

Abbott Laboratories Inc. (St Jude Medical)

Class I - Dangerous

Due to a software error, the user may lose functionality of the system or the screen may turn black during operation.

May 5, 2021 Diagnostic Equipment Nationwide View Details →