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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Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.