Cl II CARESCAPE Patient Data Module

Company:GE Medical Systems Information Technologies, Inc.
Date of Enforcement Report 12/13/2017
Class lI:


CARESCAPE Patient Data Module (PDM) v2.6 software used with CARESCAPE Monitors B850, B650, and B450 v2.0.7 or earlier softwareThe PDM is intended to provide uninterrupted acquisition of physiologic parameter data on adult, pediatric and neonatal patients during non-transport/bedside and transport patient care episodes.
Recall Number Z-0202-2018

Device does not produce a visual or audible impedance respiration APN alarm when an impedance respiration apnea event occurs.

GE Medical Systems Information Technologies, Inc., Milwaukee, WI on 7/132017. Voluntary firm initiated recall is ongoing

1,196 (1,176 US; 20 OUS)

US including NY, WI; Foreign: Australia, France, Germany.


About the author

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.

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