Z-0202-2018Class II

CARESCAPE Patient Data Module (PDM) v2.6 software used with CARESCAPE Monitors B850, B650, and B450 v2.0.7 or...

Name: Z-0202-2018 CARESCAPE Patient Data Module (PDM) v2.6 software used with CARESCAPE Monitors B850, B650, and B450 v2.0.7 or...
Creator: GE Medical Systems Information Technologies, Inc.
Published: 2017-07-13
License: https://open.fda.gov/license/

GE Medical Systems Information Technologies, Inc. / initiated 2017-07-13 / Terminated / root cause: software

FDA source

GE Medical Systems Information Technologies, Inc. began a recall of 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... on 2017-07-13. FDA classified it as Class II and gives the reason as "Device does not produce a visual or audible impedance respiration APN alarm when an impedance respiration apnea event occurs". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0202-2018
Classification: Class II
Status: Terminated
Initiated: 2017-07-13
Posted: 2017-12-06
Terminated: 2021-04-01
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.
Product code: MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Reason for recall: Device does not produce a visual or audible impedance respiration APN alarm when an impedance respiration apnea event occurs.
Root cause tag: software
FDA 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 in commerce: 1,196 (1,176 US; 20 OUS)
Distribution: Worldwide Distribution - US including NY, WI; Foreign: Australia, France, Germany.
Product codes and lots: Model No. 2042084-001. 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Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0202-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0202-2018	Class II	Terminated	Voluntary: Firm initiated	2017-12-13	2017-12-06

Product code MHX

K071073Class IISolar 8000 and Transport Pro with Patient Data ModuleGe Medical Systems Information Technologies / cleared 2007-05-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)