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U.S. Department of Health and Human Services

Medical Device Recalls
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1 to 10 of 12 Results
510(K) Number: K020715
 
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Philips HeartStart (HS1) Onsite/Home AED 2 05/23/2018 Philips Electronics North America Corp.
Automated External Defibrillator(AED) of brand name "Philips HeartStart HS1 OnSite" (Model number M5... 2 06/28/2010 Philips Medical Systems
Automated External Defibrillator (AED) of brand name "Philips HeartStart HS1 Home" (Model Number M5... 2 06/28/2010 Philips Medical Systems
Heartstart (HS1) Laerdal brand onsite Automated External Defibrillator, Model M5067A 2 03/23/2010 Philips Medical Systems
Philips Heartstart (HS1) Onsite Automated External Defibrillator (AED) Catalog number M5066A 2 03/23/2010 Philips Medical Systems
Philips defibrillator, model M5066A. Sold in the US by Philips as an OTC under the brand name Phili... 2 07/09/2008 Philips Medical Systems
Laerdal "HeartStart Defibrillator", model M5067A, under Laerdal brand for Laerdal Medical Corp, Wapp... 2 07/09/2008 Philips Medical Systems
Philips and Laerdal brands of HeartStart HS1 Defibrillator Family Model number M5066A, M5067A, and ... 2 01/04/2013 Philips Medical Systems North America Co. Phillips
Philips HeartStart Home and OnSite (HS1) automated external defibrillators (AEDs). Product Usage... 2 03/19/2014 Philips Medical Systems North America Inc.
Philips HeartStart FRx AED, Model 861304, FRx codeRev: E.02.017 2 02/19/2020 Philips North America LLC
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