FDAFDA · Food and drugs·Recall number Z-1439-2014
Philips HeartStart XL+ Defibrillator/Monitor Model number: 861290, automatic external defibrillator.
Published April 16, 2014 · Recall initiated: March 31, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
A component on the HeartStart XL+ Therapy Board could malfunction potentially affecting the ability to deliver therapy
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Philips Medical Systems, Inc.
- Distributor
- Worldwide Distribution - US Distribution including the states of IN and WA., and the countries of : CHINA FRANCE GERMANY ITALY MALAYSIA PANAMA SAUDI ARABIA TURKEY and UNITED KINGDOM.
- Lot
- Serial Numbers: USN1307680 USD1309181 USD1308456 USD1309182 USD1309167 USD1309184 USD1309168 USD1309194 USD1309180 USD1309195 USD1309196 USD1309274 USD1309197 USD1309286 USD1309227 USD1309301 USD1309264 US11409686 USD1309269
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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