Dec

2017

Cl II CARESCAPE Patient Data Module

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

PRODUCT

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

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

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

VOLUME OF PRODUCT IN COMMERCE
1,196 (1,176 US; 20 OUS)

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

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About the author

Amy Sellers

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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Cl II CARESCAPE Patient Data Module

Amy Sellers

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