McKesson Cardiology ECG Management It is a software application designed to import, display, store, analyze, distribute and manage information related to ECG procedures of adult and pediatric patients from external ECG devices.
Class I - DangerousWhat Should You Do?
- Check if you have this product: MC13.1 and MC13.1.1
- 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:
- McKesson Israel Ltd.
- Reason for Recall:
- An ECG procedure time stamp is incorrect, due to a software error in the McKesson Cardiology ECG Management with software versions 13.1 and 13.1.1.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
McKesson Cardiology ECG Management It is a software application designed to import, display, store, analyze, distribute and manage information related to ECG procedures of adult and pediatric patients from external ECG devices.
Product Codes/Lot Numbers:
MC13.1 and MC13.1.1
Distribution:
Distributed in: MA, MS, NH, NC, TX, WA
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0910-2015
Related Recalls
Change Healthcare has identified an issue where, under certain circumstances, the Real Time Monitor (RTM) may not display physiological signals.