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Recall Observatory FDA recall evidence

Device product

Philips HeartStart XL+ Defibrillator/Monitor Model number: 861290, automatic external defibrillator.

Z-1439-2014

March 31, 2014

Class II

Product summary

Firm
Philips Medical Systems, Inc.
Event
Event 67857
Status
Terminated
Classification
Class II
Quantity
19 units
Official record key
device-enforcement:Z-1439-2014

Official wording

Reason: A component on the HeartStart XL+ Therapy Board could malfunction potentially affecting the ability to deliver therapy

Code information: Serial Numbers: USN1307680 USD1309181 USD1308456 USD1309182 USD1309167 USD1309184 USD1309168 USD1309194 USD1309180 USD1309195 USD1309196 USD1309274 USD1309197 USD1309286 USD1309227 USD1309301 USD1309264 US11409686 USD1309269

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    A component on the HeartStart XL+ Therapy Board could malfunction potentially affecting the ability to deliver therapy