6/25/98 Medtronic 9790C Programmers for Kappa 400 Pacemakekers Model 9952A software: Class II 133 units. Bench testing identified a software anomaly that could result in the delivery of an unitended pacing mode or pacing interval. Recall #=Z-715-8
Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.
