GE Medical Systems Information Technologies, Inc.: 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.

Recall number

Z-0202-2018

Recalling firm

GE Medical Systems Information Technologies, Inc.

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.

Status

Terminated

Initiated

2017-07-13

Posted

not on file

Terminated

2021-04-01

Reason

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

Root cause

Software Design Change

Action

GE Healthcare sent an Urgent Medical Device Correction letter dated July 12, 2017, to all affected consignees via certified mail. Consignees were advised to enable "Resp Rate (Impedance)" alarms and set the low limits to the factory defaults (NICU: 20/minute; Adult ICU: 5/minute). Consignees were also advised to enable audible alarms under Alarm Priorities for RR (Impedance) high/low. GE will provide a correction free of charge once it is available. GE will contact consignees to arrange device corrections. Consignees were instructed to call 1-800-558-7044 or a local representative with any questions pertaining to this recall.

Quantity

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

Distribution

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

Lot, serial or model codes

Model No. 2042084-001. 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510(k) numbers

["K071073"]

PMA numbers

not on file

Product code

MHX

Firm FEI

2124823

Firm city

Milwaukee

Firm state

WI

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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