Case Cardiac Assessment System for Exercise Testing and CardioSoft Diagnostic System Exercise Stress Testing ECG application
Class I - DangerousWhat Should You Do?
- Check if you have this product: CASE and CardioSoft - v6.6x, v6.7x and v7.0
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- 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:
- GE Healthcare, LLC
- Reason for Recall:
- If a certain sequence of events occur, the pdf test report that belongs to one patient will appear in a different patient's record when viewed in an Electronic Medical Record (EMR) or a similar system.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- completed
Product Information
Full Description:
Case Cardiac Assessment System for Exercise Testing and CardioSoft Diagnostic System Exercise Stress Testing ECG application
Product Codes/Lot Numbers:
CASE and CardioSoft - v6.6x, v6.7x and v7.0
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1927-2021
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There is a potential security vulnerability in Centricity Universal Viewer (UV), Centricity PACS-IW (PACS-IW), Centricity Radiology RA600 (RA600), & Centricity Cardiology CA1000 (CA1000) where the service login credentials are able to be identified which could allow a malicious actor with these credentials to access the system and potentially manipulate patient data.
There is a potential security vulnerability in Centricity Universal Viewer (UV), Centricity PACS-IW (PACS-IW), Centricity Radiology RA600 (RA600), & Centricity Cardiology CA1000 (CA1000) where the service login credentials are able to be identified which could allow a malicious actor with these credentials to access the system and potentially manipulate patient data.