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 s…

Recall date

July 13, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0202-2018

FDA classification

Class II

Brand / firm

GE Medical Systems Information Technologies, Inc.

Sold / distributed

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

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.