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U.S. Department of Health and Human Services

Medical Device Recalls

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1 to 8 of 8 Results
510(K) Number: K110825
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Product Description
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FDA Recall
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HeartStart XL+ Defibrillator/Monitor, Model 861290 2 12/05/2019 Philips North America, LLC
HeartStart XL+ Defibrillator/Monitor, Model 861290 2 11/19/2019 Philips North America, LLC
HeartStart XL+ Defibrillator/Monitor The HeartStart XL+ is intended for use in a hospital setting... 3 03/13/2018 Philips Electronics North America Corporation
Philips HeartStart XL+ Defibrillator/Monitor Product Usage: The HeartStart XL+ is intended for u... 2 08/04/2015 Philips Electronics North America Corporation
Philips HeartStart XL+ Defibrillator/Monitor with system software version B.00.00 or B.00.01 instal... 2 04/09/2014 Philips Medical Systems, Inc.
Philips HeartStart XL+ Defibrillator/Monitor Model number: 861290, automatic external defibrillato... 2 04/09/2014 Philips Medical Systems, Inc.
Philips HeartStart XL+ Defibrillator/Monitor Model: 861290 The HeartStart XL+ is intended for us... 2 02/26/2014 Philips Medical Systems, Inc.
Philips HeartStart XL+ Defibrillator/Monitor Model number: 861290 The HeartStart XL+ is intende... 2 02/21/2013 Philips Healthcare Inc.
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