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Don’t let your AED become out of date from American Heart Association (AHA) guidelines. AEDs are designed to be updated. Also, all major AED manufacturers and their models have had software or hardware upgrades through FDA field corrective actions or FDA equipment recall notices. Extend the life of your AED as much as possible through our comprehensive database of AED recalls and updates available (most of which are free).

Physio Control Medtronic / Recalls Defibrillation Electrodes Due to Incorrect Placement Instructions for Infants Depicted on Artwork

Recall Date: 10/27/2017
Title: Recalls Defibrillation Electrodes Due to Incorrect Placement Instructions for Infants Depicted on Artwork
Units: Model/Item Numbers: 11101-000016 and 11101-000017 Lot codes: 713609, 717912, 713904, 718033, 715008, 719323, 45932237, 46042286, 45979590, 46050960, 45979954, 46052545, 46007867, 46061770, 46023185, 46063054, 46023823, 46078012 Manufacturing Dates: April 27, 2017 to August 10, 2017 Distribution Dates: May 30, 2017 to September 4, 2017 Devices Recalled in the U.S.: 7,973 units nationwide
Issue: Physio-Control Inc. is recalling infant/child defibrillation electrodes because the artwork on the pads within the packaging shows incorrect placement instructions for infants. There is no issue with the performance or function of the defibrillation electrodes. However, incorrect placement of the electrodes on an infant may result in failure to deliver an effective shock to an infant in cardiac arrest. A delay in therapy could result in serious injury and/or death.
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