GE Medical Systems Information Technologies, Inc. recalls CARESCAPE Patient Data Module (PDM) v2.6 software used with CARESCAPE Monitors B850, B650, and B450 v2.0.7 or earlier so

Recalled December 13, 2017 · FDA recall Z-0202-2018 · GE Medical Systems Information Technologies

Hazard

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

Units

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

Sold at

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

Description

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

Product

CARESCAPE Patient Data Module (PDM) v2.6 software used with CARESCAPE Monitors B850, B650, and B450 v2.0.7 or earlier software The 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. Physiological parameter data acquired by the PDM includes EGG, invasive blood pressure, non-invasive blood pressure, pulse oximetry, temperature, cardiac output and respiration. This device acquires, processes and stores information for all aforementioned parameters and transmits this information to a transport or bedside central processing unit for viewing and alarm surveillance purposes.

Manufacturer(s)

GE Medical Systems Information Technologies, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →