PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: December 13, 2017 Initiated: July 13, 2017 #Z-0202-2018

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.

Details

Units Affected
1,196 (1,176 US; 20 OUS)
Distribution
Worldwide Distribution - US including NY, WI; Foreign: Australia, France, Germany.
Location
Milwaukee, WI

Frequently Asked Questions

What product 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.. Recalled by GE Medical Systems Information Technologies, Inc.. Units affected: 1,196 (1,176 US; 20 OUS).
Why was this product recalled? ▼
Device does not produce a visual or audible impedance respiration APN alarm when an impedance respiration apnea event occurs.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 13, 2017. Severity: Moderate. Recall number: Z-0202-2018.

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