June 25, 1998
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
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Hil-rom 6/25/98 Isolette C2000 Infant Incubators Failure to assure that all inspection and testing equipment is suitable for its intended purposes and is capable of producing valid results. The inspection revealed that the _____ automated simulator test has not been updated to keep current with hardware and software changes made to the C2000 device. (FDA...
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