🔍 RecallPedia

Change Healthcare Stratus Imaging PACS 1.4 and Stratus Imaging Share 1.4, a component of Stratus Imaging PACS.

Class I - Dangerous
🏥 Medical Devices Recalled: November 1, 2023 CHANGE HEALTHCARE CANADA COMPANY Diagnostic Equipment Nationwide

What Should You Do?

  1. Check if you have this product:
    Version 1.4, UDI (01)17540262160093(10)010400
  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:
CHANGE HEALTHCARE CANADA COMPANY
Reason for Recall:
Under certain circumstances, information from HL7 messages received by Stratus PACS/Imaging Share systems has been incorrectly associated with another patient's study.
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

Change Healthcare Stratus Imaging PACS 1.4 and Stratus Imaging Share 1.4, a component of Stratus Imaging PACS.

Product Codes/Lot Numbers:

Version 1.4, UDI (01)17540262160093(10)010400

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0551-2024

Related Recalls