Recall Z-0202-2018— GE Medical Systems Information Technologies, Inc.

Name: FDA recall Z-0202-2018
Creator: U.S. Food and Drug Administration
Published: 2017-07-13

Class II · Terminated

Class II FDA medical device recall by GE Medical Systems Information Technologies, Inc., initiated 2017-07-13, terminated 2021-04-01. It names one FDA 510(k) clearance: K071073. 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.. Reason: Device does not produce a visual or audible impedance respiration APN alarm when an impedance respiration apnea event occurs..

Recalling firm: GE Medical Systems Information Technologies, Inc.
Classification: Class II
Status: Terminated
Initiated: 2017-07-13
Terminated: 2021-04-01
Firm location: Milwaukee, WI, United States

510(k) clearances named in this recall

1 on FDA's record

K071073 — SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULEGe Medical Systems Information Technologies·cleared 2007-05-11

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.