Recall Z-0487-2018— GE Medical Systems Information Technologies, Inc.

Name: FDA recall Z-0487-2018
Creator: U.S. Food and Drug Administration
Published: 2018-01-11

Class II · Terminated

Class II FDA medical device recall by GE Medical Systems Information Technologies, Inc., initiated 2018-01-11, terminated 2021-07-07. It names one FDA 510(k) clearance: K162012. Product: GE HEALTHCARE CARESCAPE Central Station (CSCS) software version 2.0.2 The CARESCAPE Central Station is intended to collect information from a network and display this data. This data includes physiological, patient demographic and/or other non-medical information. Physiological parameters and waveforms from monitors and telemetry systems can be displayed, provide alarm annunciation, and can be printed from the CARESCAPE Central Station.. Reason: CARESCAPE Central Station (CSCS) software version 2.0.2 units may experience unexpected NO COMM (No Communication) and network communication issues after boot-up or system restart..

Recalling firm: GE Medical Systems Information Technologies, Inc.
Classification: Class II
Status: Terminated
Initiated: 2018-01-11
Terminated: 2021-07-07
Firm location: Milwaukee, WI, United States

510(k) clearances named in this recall

1 on FDA's record

K162012 — CARESCAPE Central Station V2GE Healthcare·cleared 2016-09-15

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

GE HEALTHCARE CARESCAPE Central Station (CSCS) software version 2.0.2 The CARESCAPE Central Station is intended to collect information from a network and display this data. This data includes physiological, patient demographic and/or other non-medical information. Physiological parameters and waveforms from monitors and telemetry systems can be displayed, provide alarm annunciation, and can be printed from the CARESCAPE Central Station.

Reason for recall

CARESCAPE Central Station (CSCS) software version 2.0.2 units may experience unexpected NO COMM (No Communication) and network communication issues after boot-up or system restart.

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