Health product recall

CARESCAPE Central Station (2018-01-10)

Starting date:
January 10, 2018
Posting date:
January 9, 2019
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-68636

Affected prodcuts

CARESCAPE Central Station

Reason

GE Healthcare has recently become aware that after boot-up or system start up, CSCS v2.0.2 units may display unexpected no comm notifications in the patient multi-viewer or single viewer window when the CSCS is connected to both the mission critical (mc) and the information exchange (ix) networks. If a no comm notification is displayed, all patient waveforms, parameter data and alarms are lost at the CSCS and patients admitted to telemetry transmitters are unmonitored unless monitored via other central stations, bedside monitors or direct clinical observation.

Affected products

CARESCAPE Central Station

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

2051117-005

Companies
Manufacturer
GE Medical Systems Information Technologies, Inc.
8200 W Tower Ave
Milwaukee
53223
Wisconsin
UNITED STATES