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March 2017

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  • FDA: Recall Phillips Healthcare HeartStart MRx Monitor/Defibrillator

    Friday, March 24, 2017

    Phillips Healthcare recalls HeartStart MRx Monitor/Defibrillator due to electrical issues that may prevent the device from operating properly. The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.

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  • FDA: Physio-Control Inc. Recalls LIFEPAK 1000 Defibrillator

    Thursday, March 9, 2017

    Physio-Control is recalling the LIFEPAK 1000 due to an electrical issue which may cause the device to shut down unexpectedly during patient treatment. Physio-Control has determined that wear and oxidation formation between the battery and device electrical contacts may cause power interruptions. This may prevent the device from delivering the electrical shock needed to revive a patient in cardiac arrest. A delay in delivering this therapy could result in serious patient injury such as permanent organ damage, brain injury, or death.

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  • FDA Warns of Potentially Contaminated SPS-1 Static Preservation Solution Distributed by Organ Recovery Systems, Inc.

    Thursday, March 9, 2017

    The FDA wants to heighten awareness about the potential for bacterial contamination of SPS-1, and provide recommendations to health care facilities to help mitigate potential patient exposure to infectious bacteria.

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