Monitor, St Segment With Alarm
Cardiovascular · 21 CFR 870.1025
Recent MDR events
33 adverse event reports on file
- GE DATEX-OHMEDA S/5 CARDIOCAP MONITOROct 25, 2019MalfunctionDatex-ohmeda, Inc.3007409280-2019-00062
- CARDIOCAP/5Jan 26, 2018MalfunctionGe Medical Systems Information Technologies, Inc.7221058
- CARDIOCAP 5Jun 16, 2017MalfunctionGe Healthcare Finland Oy9610105-2017-00041
- CARDIOCAP 5Feb 17, 2015MalfunctionGe Healthcare Finland Oy9610105-2015-00004
- CARDIOCAP 5Jun 12, 2014MalfunctionGe Healthcare, Finland Oy9610105-2014-00013
- CARDIOCAP 5Oct 9, 2012MalfunctionGe Healthcare Finland Oy9610105-2012-00038
- CARDIOCAP 5Sep 24, 2012MalfunctionGe Healthcare Finland Oy9610105-2012-00034
- CARDIOCAP 5Aug 16, 2012MalfunctionGe Healthcare Finland9610105-2012-00029
- CARDIOCAP 5May 25, 2012MalfunctionGe Healthcare Finland Oy9610105-2012-00023
- CARDIOCAP 5Mar 26, 2012MalfunctionGe Healthcare9610105-2012-00014
Event type breakdown
Recalls
2 recall events for this product code
- GE Medical Systems Information TecnologyTerminatedSep 1, 2009
Datex-Ohmeda S/5 Critical Care Monitor with L-CICU01, L-CICU02A, L-ICU05 & L-ICUO5A software.
GE Healthcare (Datex-Ohmeda) S/5 Critical Care Monitor and S/5 Compact Critical Care Monitor with L-CICU01, L-CICU02A, L-ICU05 & L-ICUO5A software had an issue where the Heart Rate (HR) was displaying as ---(3 dashes) when the monitor was used continuously for 49 days without a cold start. A missed alarm or missed HR value could cause a delay in recognition of a cardiac event that may result i
Z-1994-2009 · View FDA record ↗ - GE Medical Systems Information TecnologyTerminatedSep 1, 2009
Datex-Ohmeda S/5 Compact Critical Care Monitor with L-CICU01, L-CICU02A, L-ICU05 & L-ICUO5A software.
GE Healthcare (Datex-Ohmeda) S/5 Critical Care Monitor and S/5 Compact Critical Care Monitor with L-CICU01, L-CICU02A, L-ICU05 & L-ICUO5A software had an issue where the Heart Rate (HR) was displaying as ---(3 dashes) when the monitor was used continuously for 49 days without a cold start. A missed alarm or missed HR value could cause a delay in recognition of a cardiac event that may result i
Z-1995-2009 · View FDA record ↗
Registered firms
224 firms currently registered for this product code
Philips North America Llc
Cambridge, MA, US
Ge Medical Systems Information Technologies
EL PASO, TX, US
Ge Medical Systems (china) Co., Ltd.
WUXI Jiangsu, CN
Cdr Manufacturing, Inc., Dba Keytronic
Oakdale, MN, US
Philips Medizin Systeme Boeblingen Gmbh
BOEBLINGEN Baden-Wurttemberg, DE
Ge Healthcare Finland Oy
HELSINKI Uusimaa, FI
Ge Medical Systems Information Technologies, Inc.
Wauwatosa, WI, US
Shenzhen Mindray Bio-medical Electronics Co., Ltd.
Shenzhen Guangdong, CN
Edan Diagnostics, Inc.
San Diego, CA, US
Philips North America Llc
Export, PA, US
Philips North America Llc
Murrysville, PA, US
Philips Electronics Ltd
Mississauga Ontario, CA
Dre Med
Louisville, KY, US
Caf Medical Solutions Inc
Hockley, TX, US
510(k) clearances
14 clearances for this product code
- Criticare Systems, Inc.Sep 1, 2010
K101602 · VITAL SIGNS MONITOR
- Philips Medical SystemsMar 13, 2008
K080461 · STAR ST AND ARRHYTHMIA SOFTWARE, RELEASE J.0
- Datex-OhmedaNov 14, 2002
K022740 · DATEX-OHMEDA S/5 COMPACT CRITICAL CARE MONITOR WITH L-CICU02 & L-CICU02A SOFTWARE
- Datex-OhmedaSep 14, 2001
K012837 · MODIFICATION TO: DATEX-OHMEDA CARDIOCAP 5 (REV B) AND ACCESSORIES
- Siemens Medical Solutions USA, Inc.Dec 5, 2000
K002105 · SIEMENS INFINITY SC 6002XL ENHANCED WITH ST SEGMENT ANALYSIS
- Datex-Ohmeda, Inc.Nov 1, 1999
K992323 · DATEX-OHMEDA CARDIOCAP 5, F-MX, F-MXG AND ACCESSORIES
- Medical Data ElectronicsNov 25, 1998
K982104 · ESCORT-LINK CENTRAL STATION MONITOR MODEL 20500
- Siemens Medical Solutions USA, Inc.Feb 26, 1998
K974492 · SIEMENS SC6000/SC6000P BEDSIDE MONITORING SYSTEM ENHANCED WITH ST SEGMENT ANALYSIS