Day

February 15, 2019
Company: Medtronic, Inc. Date of Enforcement Report: 1/17/2019 Class I: PRODUCT Medtronic’s Dual Chamber Implantable Pulse Generators (IPGs) are implanted cardiac pacemakers used to provide stimulation to increase heart rate in patients with a slow heart rhythm (bradycardia) or no heart rhythm. The pulse generator is the small implanted unit containing the battery and other...
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The West Australian reported that two autonomous haulage systems (AHS) trucks experienced a collision when one of the trucks backed into the cab of the second truck that was stationary at the time.  This is of interest to us as the AHS trucks are software controlled and they crashed.  Clearly a failure mode.  The initial report is...
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Agile Methods for Medical Device and Health IT Software

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