Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Medical Device Recalls
  • Print
  • Share
  • E-mail
-
1 to 243 of 243 Results
Product: ecg
Results per Page
New Searchexport reports to excelExport to Excel | HelpHelp
Product Description
Sort by Product Name [A-Z]
Sort by Product Name [Z-A]
Recall
Class
Sort by Recall Class [0-9]
Sort by Recall Class [9-0]
FDA Recall
Posting Date
Sort by Date Classified [0-9]
Sort by Date Classified [9-0]
Recalling Firm
Sort by Recalling Firm [A-Z]
Sort by Recalling Firm [Z-A]
Procedure packs: (1) Presource PBDS Cat. PNVMNIB21, Kit, Neuro IMAS, Sterile; (2) Presource PBDS... 2 10/10/2023 Cardinal Health 200, LLC
Procedure packs: (1) Presource PBDS Cat. PN33BPCR2, Kit, Back, Sterile; (2) Presource PBDS Cat. POC... 2 10/10/2023 Cardinal Health 200, LLC
Baxter Epiphany Cardio Server E3 ECG Management System Servers with software versions: a) v6.1.x, b... 2 09/28/2023 Baxter Healthcare Corporation
Draeger Infinity M300 and M300+, for use with the ICS to monitor ECG and pulse oximetry on ambulator... 2 04/27/2023 Draeger Medical Systems, Inc.
Scan Monitor/ScanWatch, model number hwa09 Wearable, Bluetooth-connected wrist watch that records... 2 03/22/2023 Withings
Zio AT Clinical Reference Manual, Part: ALB0031, and Zio AT Important Information Pamphlet, Part: AL... 2 11/04/2022 iRhythm Technologies, Inc.
3M Red Dot Electrodes, Radiolucent Monitoring Electrode with Foam Tape, Catalog No. 2244, (3M ID (SK... 2 11/01/2021 3M Company - Health Care Business
Arrow Pacing Catheter Kit-Bipolar Electrode Catheter 5 Fr. 110 cm, Product Code: AI-05210 - Product ... 2 07/13/2021 Arrow International Inc
Arrow Temporary Pacing Catheter/Introducer Kit 6Fr. pacing catheter 7Fr. introducer Product Code: A... 2 07/13/2021 Arrow International Inc
Arrow Bipolar Balloon Electrode Catheter 5 Fr. 105 cm, Product Code: AI-07154 - Product Usage: inte... 2 07/13/2021 Arrow International Inc
Arrow Temporary Pacing Catheter/Introducer Kit 5Fr. pacing catheter 6 Fr. introducer Product Code: ... 2 07/13/2021 Arrow International Inc
Case Cardiac Assessment System for Exercise Testing and CardioSoft Diagnostic System Exercise Stress... 2 06/22/2021 GE Healthcare, LLC
Novaplus Monitoriing Electrode with Foam Tape and Sticky Gel - Product Usage: intended to be used b... 2 11/05/2020 3M Company - Health Care Business
3M Red Dot Monitoring Electrode with Foam Tape - Product Usage: intended to be used by healthcare pr... 2 11/05/2020 3M Company - Health Care Business
3M Red Dot Monitoring Electrode with Foam Tape - Product Usage: intended to be used by healthcare pr... 2 11/05/2020 3M Company - Health Care Business
3M Red Dot Monitoring Electrode with 4mm Adapter - Product Usage: intended to be used by healthcare ... 2 11/05/2020 3M Company - Health Care Business
Novaplus Monitoriing Electrode with Foam Tape and Sticky Gel - Product Usage: intended to be used b... 2 11/05/2020 3M Company - Health Care Business
DDU-2450 Lifeline ECG Model Numbers DDU-A2450EN DDU-E2450DE DDU-E2450EN DDU-E2450FR DDU-E2450... 2 06/17/2020 Defibtech, LLC
Replaceable lead set for the Wireless Acquisition Module (WAM), which is the ECG front-end for vario... 2 04/29/2020 WELCH ALLYN, INC/MORTARA
S4 and patient cable for the S4 Wireless Telemeter with the following device names: CABLE 10 WIRE LF... 2 04/29/2020 WELCH ALLYN, INC/MORTARA
T12. Incorporates wireless electrocardiographic technology to achieve the real-time acquisition and ... 2 04/29/2020 WELCH ALLYN, INC/MORTARA
ELI PC. The ELI PC Service automatically converts resting ECG recordings collected with WAM PC patie... 2 04/29/2020 WELCH ALLYN, INC/MORTARA
Q-Stress/XScribe. Q-Stress or XScribe is a diagnostic device capable of real time ECG display, heart... 2 04/29/2020 WELCH ALLYN, INC/MORTARA
McKesson Cardiology ECG Management, Change Healthcare Cardiology ECG Management 2 04/08/2020 CHANGE HEALTHCARE CANADA COMPANY
LifePAK 500 Automated External Defibrillator, model numbers: 3005400-XXX, U3005400-XXX, 3011790-XXX/... 2 04/01/2020 Physio-Control, Inc.
Toco+ transducer with ECG/IUP capability (wired), that may have been serviced with the following: Pa... 2 02/12/2020 Pacific Medical Group Inc.
ApexPro Telemetry System - Product Usage: The ApexPro Telemetry System is intended for use under the... 2 12/20/2019 GE Healthcare, LLC
myCordella Patient Kit without ECG, The Cordella System is a comprehensive at-home heart failure man... 2 11/22/2019 ENDOTRONIX
Lemon Prep: MD0019T - 4 oz tubes MD0019--SUP - Single Use Cups Skin preparation used to enhance... 2 11/13/2019 Carroll-Baccari, Inc.
Pedia Prep: MD0033T - 4 oz tubes MD0033--SUP - Single Use Cups Skin preparation used to enhan... 2 11/13/2019 Carroll-Baccari, Inc.
Philips 5-Lead Set, Disposable, Bedside, AAMI Model # 989803173131 Product Usage: Philips Singl... 2 09/09/2019 Philips North America, LLC
HeartStart MRx Monitor/Defibrillator Model # M3535A - Product Usage: The HeartStart MRx is a lightw... 2 09/06/2019 Philips North America, LLC
POWERPORT CLEARVUE isp, 6F CHRONOFLEX Catheter, Intermediate NAUTILUS DELTA Kit; POWERPORT CLEARV... 2 07/25/2019 Bard Peripheral Vascular Inc
ZOLL AED PRO Automated External Defibrillator Product Usage: The AED PRO unit is intended to def... 2 07/03/2019 ZOLL Medical Corporation
Leadwire sets with snap ends: REF/Catalog Number Description 2106381-001 ECG Leadwire set, 5-lead,... 3 06/26/2019 GE Healthcare, LLC
Replacement leadwires with grabber ends: REF/Catalog Number Description 2106388-005 Replacement EC... 3 06/26/2019 GE Healthcare, LLC
ECG leadwire sets: REF/Catalog Number Description 2106389-001 ECG Leadwire set, 5-lead, grouped, ... 3 06/26/2019 GE Healthcare, LLC
ECG Trunk Cables: REF/Catalog Number Description 2106305-001 ECG Trunk Cable, 3/5-lead, AHA, 3.6 ... 3 06/26/2019 GE Healthcare, LLC
Replacement ECG leadwires with snap ends REF/Catalog Number Description 2106386-101 Replacement EC... 3 06/26/2019 GE Healthcare, LLC
Integrated ECG cable with 3-lead leadwires labeled as the following: 1. ECG TRUNK CABLE, 3-LD W... 3 03/26/2019 GE Healthcare, LLC
EtCO2 Module -Part Number: 02.01.210699 Monitors: iM80, iM50, M50, iM70, iM60, iM8, iM8A, iM8B Patie... 2 10/11/2018 Edan Diagnostics
GE Healthcare CARESCAPE Monitor B450 Product Usage: Intended uses of CARESCAPE B450 in 510(k) co... 2 10/10/2018 GE Healthcare Finland Oy
GE Healthcare CARESCAPE Monitor B850 Product Usage: Intended uses of CARESCAPE B850 V2 in 510(... 2 10/10/2018 GE Healthcare Finland Oy
ARROW® Bipolar Electrode Catheter with shrouded pins , 6 Fr, 110 cm Product Code: AI-06210-S Pro... 2 09/19/2018 Arrow International Inc
Philips SureSigns VM 3/4/6/8 Patient Monitors, 863063 863064 863065 863066 863068 863077 86308... 2 08/22/2018 Philips Electronics North America Corporation
VPS Rhythm ECG Accessory Pack with Johans Adapter, REF RHY-100-ECGJ Product Usage: To provide re... 2 07/08/2018 Arrow International Inc
Peripherally Inserted Midline Catheter Kit with Placement Wire, REF MK-02031-TW Product Usage: T... 2 07/08/2018 Arrow International Inc
VPS TipTracker Stylet Accessory, REF RHY-177-TTSAP Product Usage: To provide real time tip locat... 2 07/08/2018 Arrow International Inc
VPS Rhythm ECG Accessory Pack, REF RHY-100-ECGO Product Usage: To provide real time tip location... 2 07/08/2018 Arrow International Inc
BCI Advisor Vital Signs Monitor, Model 9200, Reorder numbers 920654235, 920654235, 920654335A, and 9... 2 07/06/2018 Smiths Medical ASD Inc.
Xper Flex Cardio Physiomonitoring System The Xper Flex Cardio physiomonitoring system is used to ... 2 06/07/2018 Invivo Corporation
Arrow-Johans" ECG Adapter for Right Atrial Electrocadiography (RAECG); Product Code: EG-04900 ... 2 05/30/2018 Arrow International Inc
VPS Rhythm ECG Accessory Pack with Johans Adapter; Product codes: RHY-100-ECGJ 2 05/30/2018 Arrow International Inc
VPS Rhythm ECG Accessory Pack ; Product codes: RHY-100-ECGO 2 05/30/2018 Arrow International Inc
ECG Out Cable - Heartstart MRx M1783A/M5526A 12-pin Sync cables All units of Philips sync cables... 2 01/14/2018 Philips Electronics North America Corporation
Fukuda Denshi patient monitor model DS-8100M and DS-8100N Product Usage: Use of the Fukuda Densh... 2 12/06/2017 Fukuda Denshi Co., Ltd.
Xper Flex Cardio PhysioMonitoring system The Xper Flex Cardio physiomonitoring system is used to f... 2 11/09/2017 Invivo Corporation
Masimo SPO2 Sensor, ear clip-adult (Merge Part Number: HW-HEMO-00047), Product Usage: Merge Hem... 2 06/29/2017 Merge Healthcare, Inc.
SpO2 connecting cable for Masimo LNCS sensor (Merge Part Number: HW-HEMO-00014), Product Usage: ... 2 06/29/2017 Merge Healthcare, Inc.
MasimoSET LNOP DCIP pediatric/slender digit SpO2 reusable sensor, finger clip pediatric (Merge Part... 2 06/29/2017 Merge Healthcare, Inc.
MasimoSET LNOP DCI adult SpO2 reusable sensor, adult finger clip (Merge Part Number: HW-HEMO-00075),... 2 06/29/2017 Merge Healthcare, Inc.
Monica Novii Wireless Patch System product Usage: Novii Interface - The Novii Interface is an ac... 2 05/25/2017 MONICA HEALTHCARE LTD
Philips IntelliVue MX4O WLAN Patient Wearable Monitor Product: 865352 Exchange part (service numbe... 2 04/04/2017 Philips Electronics North America Corporation
Celerity ECG Cable Accessory Pack, STERILE, Rx ONLY - distributed under the following labels: (a) an... 2 02/03/2017 Angiodynamics Inc. (Navilyst Medical Inc.)
Merge Hemo software. Merge Hemo monitors, measures, and records physiologic data from a human pa... 2 11/28/2016 Merge Healthcare, Inc.
The ORCHESTRA PLUS Programmer A portable device, equipped with a microprocessor used to program ... 2 11/15/2016 Sorin Group USA, Inc.
The ORCHESTRA Programmer A portable device, equipped with a microprocessor used to program and i... 2 11/15/2016 Sorin Group USA, Inc.
Patient Cable. Part Numbers: 4460, 6735. Sterile within Chipboard Boxes within corrugated cartons. ... 2 09/08/2016 Blackrock Microsystems, LLC
Neural Signal Amplifier. Part Numbers: 4208, 5703, 5749, 5748, 5747. Product Usage: The Blackroc... 2 09/08/2016 Blackrock Microsystems, LLC
Mindray DS USA Inc., Passport Series Patient Monitor intended for monitoring, displaying, reviewing,... 2 08/16/2016 Mindray DS USA, Inc. dba Mindray North America
91496 Ultraview SL Command Module, Options A, B, C, and I. Option A: ECG/Respiration, SpO2, Tempe... 2 08/04/2016 Spacelabs Healthcare Inc
AmediCheck Instant Test Cup, Part No. C-C0501A-3A Product Usage: The AmediCheck Instant Test Cup... 3 08/01/2016 Branan Medical Corporation
Reveal LINQ insertable Cardiac Monitor, Model LNQ11. Monitors subcutaneous ECG continuously. 2 03/25/2016 Medtronic Inc.
Remote Patient Monitoring System, MDP 2000 Series, Part Numbers: MDP2040-0100, PGM340R3, or PGM340R4... 2 01/04/2016 Vidco, Inc.
CNSystems TASK FORCE MONITOR 3040i, plethysmograph, impedance. Noninvasively measure and display pa... 2 01/04/2016 Partners In Medicine Llc
ECG Electrodes: 50007  Stablebase SBW55 50675  Stablebase SBW55-15 58051  Skintact W-60 505... 2 11/18/2015 Leonhard Lang Medizintechnik GmbH
ECG Out Cable,for use with a Philips ALS monitor/ defibrillator and bedside monitor for Synchronize... 2 11/13/2015 Philips Electronics North America Corporation
Medtronic Achieve Cables, model 990066. The sterile, single use only Electrical Cable (Model 990066... 2 11/02/2015 Medtronic Inc.
Spacelabs Healthcare CardioCall ECG Event Recorder, Models VS20, VS20x4, ST80, ST80x4, PCBAs PN # 67... 2 10/30/2015 Spacelabs Healthcare Inc
Mindray DPM 7 Monitor, Multi Parameter Patient Monitor (with Arrhythmia Detection and Alarms) Int... 2 09/04/2015 Mindray DS USA, Inc. dba Mindray North America
Physio-Control QuikCombo Pacing/Defibrillation/ECG Electrodes RediPak® Preconnect System Item Cod... 2 09/02/2015 Covidien LLC
Ultraview SL Command Modules, Model 91496-M, upgraded with the Masimo SpO2 Option. Product Usage... 2 04/28/2015 Spacelabs Healthcare Inc
Skintact ECG Electrode FS-50, Catalog no. 58028 , & Stable Base ECG Electrode SBT-60, Catalog no. ... 2 03/28/2015 Leonhard Lang Medizintechnik GmbH
Lithium Polymer Fiber Optic Module Batteries used in the Intera MR System upgraded to CDAS, Part Num... 2 03/20/2015 Philips Medical Systems, Inc.
Spacelabs Healthcare qube Compact Monitor, Model 91390. The Spacelabs Healthcare qube Compact M... 2 02/24/2015 Spacelabs Healthcare Inc
Alive ECG App 2.1.2 ( a medical device application for the Apple iOS operating system, intended to b... 3 02/18/2015 Alivecor SFO
McKesson Cardiology ECG Management It is a software application designed to import, display, stor... 2 01/05/2015 McKesson Israel Ltd.
ADULT Radiotranslucent Electrode, Part number T100-PHILIPS, Rx ONLY, For use with Philips HeartStart... 1 12/24/2014 Heart Sync, Inc.
ADULT Radiotranslucent Electrode, Part number T100LO-PHILIPS, Rx ONLY, For use with Philips HeartSta... 1 12/24/2014 Heart Sync, Inc.
ADULT/CHILD Radiotransparent Electrode, Part number C100AC-PHILIPS, Rx ONLY, For use with Philips He... 1 12/24/2014 Heart Sync, Inc.
ADULT Radiotransparent Electrode, Part number C100-PHILIPS, Rx ONLY, For use with Philips HeartStart... 1 12/24/2014 Heart Sync, Inc.
ADULT/CHILD Radiotranslucent Electrode, Part number T100AC-PHILIPS, Rx ONLY, For use with Philips He... 1 12/24/2014 Heart Sync, Inc.
CONMED ADULT R2 Multifunction Electrodes, REF/Catalog Number 3115-1751, Direct Connect to Philips He... 1 12/04/2014 ConMed Corporation
ADULT Radiotransparent Electrode, REF/Catalog Number 2001H, Rx ONLY --- COMPARABLE TO PHILIPS MEDICA... 1 12/04/2014 ConMed Corporation
MINI PEDIATRIC Radiotransparent Electrode, REF/Catalog Number 2602H, Rx ONLY --- COMPARABLE TO PHILI... 1 12/04/2014 ConMed Corporation
CONMED PEDIATRIC R2 Multifunction Electrodes, REF/Catalog Number 3115-1750, Direct Connect to Philip... 1 12/04/2014 ConMed Corporation
Cardiac Function Analysis Software Product Data No. MPDCT0301EAD CSCF-003A The software is applic... 2 11/26/2014 Toshiba American Medical Systems Inc
Cardiac Function Analysis Software Product Data No. MPDCT0301EAD CSCF-003A The software is appl... 2 11/26/2014 Toshiba American Medical Systems Inc
Mortara Surveyor S12 and Surveyor S19 Patient Monitors. Product Usage: They are indicated for us... 2 10/22/2014 Mortara Instrument, Inc
Mindray V21, Size: 515 mm X 335 mm X 685 mm, N.W.: 8 kg, G.W.: 11 kg, Qty:1 The V-Series Monitor ... 2 10/21/2014 Mindray DS USA, Inc. dba Mindray North America
Spacelabs Medical Patient Monitor is a Physiological, Patient monitor With Arrhythmia Detection or A... 2 09/25/2014 Spacelabs Healthcare Inc
Philips IntelliSpace ECG Management System, with software option C61 needed to import ECGs from the... 2 08/21/2014 Philips Medical Systems, Inc.
DPM 6 Monitor in use with a Multi Parameter Module (MPM). Patient monitor used for monitoring, disp... 2 05/13/2014 Mindray DS USA, Inc. dba Mindray North America
GE Healthcare CARESCAPE Monitor B650 and CARESCAPE Monitor B850. K102239 CARESCAPE Monitor B650 T... 2 03/11/2014 GE Healthcare, LLC
GE Healthcare Solar 8000M and Solar 8000i Patient Monitor software version 5.4, 5.5, or 5.6 with the... 2 03/06/2014 GE Healthcare, LLC
Invivo Corporation Expression IP5 Information Portal Product Usage: The Expression Informati... 2 02/26/2014 Invivo Corporation
CARESCAPE Monitor B850, a multi-parameter high acuity patient monitor intended for use in multiple a... 2 02/04/2014 GE Healthcare, LLC
GE Healthcare CARESCAPE Monitor B650 and CARESCAPE Monitor B850. The CARESCAPE Monitor B650 is a ... 2 01/28/2014 GE Healthcare, LLC
SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE (Marketed As GE Healthcare CARESCAPE Patient D... 2 01/22/2014 GE Healthcare, LLC
GE Healthcare, TRAM MODULE, High-acuity patient monitoring. Product Usage: The TRAM Module is intend... 2 01/22/2014 GE Healthcare, LLC
The Propaq LT Series monitors. Model numbers 802LTAN, 802LT0N, and 802LTRN. These devices are ind... 2 01/07/2014 Welch Allyn Protocol, Inc
HGE Healthcare Patient Monitor B30, Procare Monitor B20, Procare Monitor B40, and Monitor B40 K1222... 2 12/12/2013 GE Healthcare, LLC
Multi Parameter Patient Monitor (with Arrhythmia Detection and Alarms) Product Usage: The V Se... 2 11/25/2013 Mindray DS USA, Inc. dba Mindray North America
DRI Cocaine Metabolite Assay, labeled as Multigent Cocaine Assay for Abbott Laboratories. 100 ml, I... 2 09/23/2013 Microgenics Corp
The Discovery NM/CT 570c CT Standalone Scan The Discovery NM/CT 570c hybrid system is a combinat... 2 08/20/2013 GE Healthcare, LLC
ViSi Mobile Chest Sensor (3 lead-wire ECG, AAMI), Catalog No. 93-10014 The ViSi Mobile Monitoring... 2 07/29/2013 Sotera Wireless, Inc.
The LIFEPAK 500 Automated External Defibrillator is a semi-automatic defibrillator that uses a paten... 2 07/19/2013 Physio Control, Inc.
Cardio Medical Products, Inc. Defibrillation/Cardioversion/Monophasic or Biphasic Pacing/ECG Electro... 2 07/08/2013 Cardio Medical Products
Vermed, Inc Radiotransparent Defibrillation Electrodes Monophasic or biphasic compatible defibrilla... 2 05/30/2013 Heart Sync, Inc
Heart Sync C100-Physio Radiotransparent Defibrillation Electrodes Monophasic or biphasic compatible ... 2 05/30/2013 Heart Sync, Inc
Medi-Trace Cadence Pediatric Radiotransparent Defibrillation Electrode Product ID: 22550P. Inten... 2 04/29/2013 Covidien LLC
Medi-Trace Cadence Adult Radiotransparent Defibrillation Electrode Product ID: 22550R. Intended ... 2 04/29/2013 Covidien LLC
Spacelabs Smart Disclosure System, Model 92810, is an integrated component of the Intesys Clinical S... 2 01/17/2013 Spacelabs Healthcare, Llc
Mindray V12 Size: 320 mm X 320 mm X 450 mm N.W.: 3 kg G.W.: 6 kg Qty:1 Manufactured in China Min... 2 12/17/2012 Mindray DS USA, Inc. d.b.a. Mindray North America
DPM 6/7 Patient Monitor Manufactured in China for : Mindray DS USA, Inc. 800 MacArthur Blvd. Ma... 2 12/11/2012 Mindray DS USA, Inc. d.b.a. Mindray North America
Zoll X Series Defibrillator/Pacemaker/Monitor Product Usage: The product is used by qualified me... 2 09/17/2012 ZOLL Medical Corporation
CARTO 3 V1.05(FG-5400-00). The CARTO 3 V1.05 System is intended for catheter-based atrial and ven... 2 09/12/2012 Biosense Webster, Inc.
V Series Patient Monitors; Mindray DS USA, Inc. Product Usage: The V Series Monitor is intended ... 2 08/28/2012 Mindray DS USA, Inc. d.b.a. Mindray North America
The product is Pathfinder SL, version 1.6.0.3057 software used with the Spacelabs Healthcare Pathfin... 2 06/20/2012 Spacelabs Healthcare, Llc
Product is the Spacelabs Medical Xprezzon Bedside Monitor, Model 91393. The Xprezzon Bedside Moni... 2 06/05/2012 Spacelabs Healthcare, Llc
QRS Diagnostic Universal ECG 12 Channel ECG (IEC), Rx only, REF Z-7000-0400, Manufactured for QRS Di... 2 03/23/2012 Qrs Diagnostic
Powerheart G3 Automated External Defibrillators (Non-Wearable) and include the following models: Pow... 1 02/27/2012 Cardiac Science Corporation
V Series Monitor Mindray DS USA, Inc. 800 MacArthur Boulevard. Mahwah, NJ 07430 The Indication... 2 02/24/2012 Mindray DS USA, Inc. d.b.a. Mindray North America
Multi-Analyte Urine DAU Calibrator (15 mL); Multi-Analyte,Intermediate Calibrator; for in-vitro di... 2 01/25/2012 Lin-Zhi International Inc
R2 Adult R2 Non-Radiolucent Multifunction Electrodes, Catalog/REF No. 3200-1715, NON-STERILE, MADE I... 2 01/25/2012 ConMed Corporation
Spacelabs Medical Ultraview SL Command Module, Model 91496. The Spacelabs Multi-parameter Module ... 2 01/17/2012 Spacelabs Healthcare, Llc
Affected device is Model 98400-SL6-AHA, CardioExpress Electrocardiograph. The ECG cable part number ... 2 01/13/2012 Del Mar Reynolds Medical, Ltd.
R2 Adult Zoll Non-Radiolucent Multifunction Electrodes, Catalog/REF 3111-1721, NON-STERILE, ASSEMBLE... 2 01/12/2012 ConMed Corporation
Ultraview SL Command Module is the Spacelabs Multi-parameter Module. It is intended for use with th... 2 01/11/2012 Spacelabs Healthcare, Llc
Lifescreen Apnea is Lifescreen ECG Screening System, Version 3.31. Lifescreen Apnea is indicate... 2 01/11/2012 Del Mar Reynolds Medical, Ltd.
ACT Cellular Phone Monitor; a component of the ACT Ambulatory Cardiac Telemetry; an automatically ac... 2 11/17/2011 Lifewatch Services Inc
LifeStar ACT III Platinum Sensor Ambulatory Cardiac Telemetry; an automatically activated system wit... 2 11/17/2011 Lifewatch Services Inc
LifeStar ACT I Sensor Ambulatory Cardiac Telemetry; an automatically activated system with a single ... 2 11/17/2011 Lifewatch Services Inc
ECG Cable Part Number: 01.57.471017 for use with the SE-1 series, SE-3 series and SE-601 series Smar... 2 10/12/2011 Edan Instruments, Inc.
Powerheart Automated External Defibrillator (AED), G3 is indicated for emergency treatment of victim... 2 09/19/2011 Cardiac Science Corporation
The 91220 mCare 300 Vital Signs monitor has a 10.4 inch resistive touchscreen display. The Spacel... 2 09/12/2011 Spacelabs Healthcare, Incorporated
Spacelabs Medical Patient Monitor is a Physiological, Patient monitor With Arrhythmia Detection or A... 2 08/17/2011 Spacelabs Healthcare, Llc
Spacelabs Medical elance Vital Signs Monitor, Model 93300. The Spacelabs elance Vital Signs Monit... 2 08/15/2011 Spacelabs Healthcare, Llc
Automated External Defibrillator (non-wearable). Model number 9200, 9200N, 9200DN, 9200RD, 9210N, 9... 2 08/03/2011 Cardiac Science Corporation
The LIFEPAK 500 Automated External Defibrillator is a semi-automatic defibrillator that uses a paten... 2 07/26/2011 Physio Control, Inc.
IQecg IQiC Interface, Part Numbers: 4-100-1407, Software Version 6.0 IQecg is to be used, under t... 2 07/14/2011 Brentwood Medical Technology Corp
IQecg IQdevices SDK, Part Numbers: 4-100-1403, Software Version 8.3.2 Product Usage: IQecg is to... 2 07/14/2011 Brentwood Medical Technology Corp
IQecg IQmanager Diagnostic Workstation, Part Numbers: 4-100-1200, Software Version 8.0.1, 8.3, 8.3.1... 2 07/14/2011 Brentwood Medical Technology Corp
12-lead ECG Cable Assembly contains the following cable and attachments: Main Cable with Limb Lea... 3 06/22/2011 Physio Control, Inc.
Datascope/ Maquet IABPs. System 98/98XT Intra-Aortic Balloon Pump; CS100/CS100i Intra-Aortic Ball... 1 06/13/2011 Maquet Datascope Corp - Cardiac Assist Division
Zoll E Series BLS Defibrillator/Pacemaker/Monitor Software versions 7.10 and 7.11 The product is... 2 05/25/2011 ZOLL Medical Corporation
TEMPUS IC PROFESSIONAL Patient Monitor, Part No. 00-1002, Manufactured by: Remote Diagnostics Techn... 2 05/11/2011 Remote Diagnostic Technologies Ltd.
Ultraview SL Patient Monitor, Model 91387. All modules may be affected except Models 90470, 90478, ... 2 05/03/2011 Spacelabs Healthcare, Llc
GE The CARESCAPE Monitor B850 includes both new and existing subsystems interconnected to form a ... 2 04/08/2011 GE Healthcare, LLC
The LIFEPAK 20 defibrillator/monitor and LIFEPAK 20e. Product part numbers: 3202487-xxx, 3202488-0... 2 03/18/2011 Physio Control, Inc.
The LIFEPAK12 Defibrillator/Monitor. The LIFEPAK12 Defibrillator/Monitor can be used in AED mode, m... 2 03/04/2011 Physio Control, Inc.
GE Healthcare, ApexPro Telemetry System The ApexPro Telemetry System is intended for use under the... 2 03/03/2011 GE Healthcare, LLC
Neotrode Wire Attached, Catalog Number: 1731-003; Neotrode II Wire Attached, Catalog Number: 1741-00... 2 03/02/2011 ConMed Corporation
Horizon Cardiology ECG Management This is a software application designed for use in various hospit... 2 01/13/2011 McKesson Provider Technologies - Medical Imaging Group
HeartStart FR2+ AED with ECG Display, Model 989803148601. This product is G2005 Update according t... 2 11/29/2010 Philips Medical Systems
HeartStart FR2+ AED with Text Display (No ECG), Model 3841, Laerdal brand, no configurable manual ch... 2 11/29/2010 Philips Medical Systems
HeartStart FR2+ AED with Text Display (No ECG), Model M3861, Philips brand, no configurable manual c... 2 11/29/2010 Philips Medical Systems
HeartStart FR2+ AED with ECG Display, Model M3860, Philips brand, configurable manual charge in adva... 2 11/29/2010 Philips Medical Systems
HeartStart FR2+ AED with ECG Display, Model 3840, Laerdal brand, configurable manual charge in advan... 2 11/29/2010 Philips Medical Systems
HeartStart FR2+ automated external defibrillator (AED) model: M3841: LAERDAL brand; text prompts onl... 2 11/26/2010 Philips Medical Systems
HeartStart FR2+ automated external defibrillator (AED) model: M3861: PHILIPS brand; text prompts o... 2 11/26/2010 Philips Medical Systems
HeartStart FR2+ automated external defibrillator (AED) Model M3860: Philips brand; configurable ECG ... 2 11/26/2010 Philips Medical Systems
HeartStart FR2+ automated external defibrillator (AED) model: M3840: LAERDAL brand; configurable ... 2 11/26/2010 Philips Medical Systems
3M Red Dot Monitoring Electrode, Catalog #2560 & Novaplus Universal Monitoring Electrode #V2560, use... 2 09/07/2010 3M Company / Medical Division
Intesys Clinical Suite (ICS) G2 92810 Smart Disclosure. The Smart Disclosure product collects patie... 2 08/25/2010 Spacelabs Healthcare, Incorporated
GE Healthcare, CARESCAPE" Monitor B850, Software version 1.0.1.13 and 1.0.2.1 The CARESCAPE " Mo... 2 06/11/2010 Ge Healthcare, Llc
Responder 2000 Defibrillator/Monitor Models: 2025653, 2026109, and 2026114. Intended use: The Re... 2 05/26/2010 Cardiac Science Corporation
Unilect ECG Electrodes Unomedical, McAllen Texas. Intended use:Cardiac monitoring 2 04/22/2010 ConvaTec
Responder 2023440 automated external defibrillator. This semi-automatic model requires the user t... 2 04/06/2010 Cardiac Science Corporation
Powerheart 9390E automated external defibrillator. This semi-automatic model requires the user to... 2 04/06/2010 Cardiac Science Corporation
Powerheart 9390A automated external defibrillator. This fully automatic model does not require th... 2 04/06/2010 Cardiac Science Corporation
Powerheart 9300P automated external defibrillator. This semi-automatic model requires the user to... 2 04/06/2010 Cardiac Science Corporation
Powerheart 9300E automated external defibrillator. This semi-automatic model requires the user to... 2 04/06/2010 Cardiac Science Corporation
Powerheart 9300A automated external defibrillator. This fully automatic model does not require the ... 2 04/06/2010 Cardiac Science Corporation
Cardiovive 92532 automated external defibrillator. This semi-automatic model requires the user to... 2 04/06/2010 Cardiac Science Corporation
GE Healthcare MAC 800 RESTING ECG ANALYSIS SYSTEM. The MAC 800 is a portable EGG acquisition, ana... 2 01/21/2010 GE Medical Systems, LLC
Heartstart FR2+ automated external defibrillator models M3861A and M3841A are NOT equipped with the ... 2 12/08/2009 Philips Medical Systems
Heartstart FR2+ automated external defibrillator Models M3860A and M3840A are equipped with an ECG M... 2 12/08/2009 Philips Medical Systems
SureSigns Patient Monitors (VM3, VM4. VM6. VM8): VM3 3/5 lead ECG/SPo2, Respiration Bedside P... 2 11/23/2009 Philips Healthcare Inc.
AGFA IMPAX HeartStation ECG Management System. 3 11/18/2009 AGFA Corp.
Spacelabs Medical Integrated ECG Cable are supplied as part of the start-up kits provided with some ... 2 09/11/2009 Spacelabs Healthcare, Incorporated
M3811B Philips Telemonitoring Clinical Review Software part of Philips Telemonitoring System, M3810A... 2 10/10/2008 Philips Medical Systems
Ultraview Digital Telemetry Transmitter, Model 91341-09 The Spacelabs Medical Digital Telemetry sys... 2 09/25/2008 Spacelabs Healthcare, Incorporated
Philips Telemonitoring System Software (M3811B) used with Philips Telemonitoring System (M3810B) ... 3 09/18/2008 Philips Medical Systems
Ultraview Digital Telemetry Transmitter, Model 90478 The Spacelabs Medical Digital Telemetry system... 2 09/18/2008 Spacelabs Healthcare, Incorporated
LS-202 Large LeadWear Combo Pack - Disposable ECG Monitoring component intended for use as a radiofr... 2 09/16/2008 Lifesync Corporation
LIFEPAK 1000 defibrillator - portable battery powered semi-automated model that can be operated in e... 2 09/16/2008 Physio Control, Inc.
LS-232 Large 12 LeadWear Single Pack - Disposable ECG Monitoring component intended for use as a rad... 2 09/16/2008 Lifesync Corporation
Zoll E Series Defibrillator with 12 Lead ECG, Automated external defibrillator, Software Version 3.0... 2 06/28/2008 ZOLL Medical Corporation, World Wide Headquarters
ECG Lead Set 60 in SOC to Snap model number 8049-1. Filter, mask, and/or accessories for sleep the... 2 04/24/2008 Respironics, Inc.
Non-continuous ventilator accessories under the following brand names: a) Adult ECG Electrodes model... 2 04/24/2008 Respironics, Inc.
BCI Autocorr Plus Pulse Oximeter/ECG/Respiration Monitor, Catalog Numbers, 3404001 (including S) and... 3 09/21/2007 Smiths Medical PM, Inc.
QRS Card 12 Lead Resting & Stress ECG Machine with Blue Tooth (wireless) interface. Cardiology Suite... 2 04/04/2007 Pulse Biomedical Inc
LifeSync ECG System - Disposable leadwear, Ls-222, Ls-223 2 02/27/2007 GMP Companies/Lifesync Corporation
BCI 3404 Autocorr Plus Pulse Oximeter/ECG/Respiration Monitor. Smiths Medical PM, Inc. This devic... 2 12/19/2006 Smiths Medical PM, Inc.
Advisor Vital Signs Monitor (model 9200), catalog number 92E654335, with Impedance Respiration board... 3 11/30/2005 Smiths Medical PM, Inc.
Advisor Vital Signs Monitor (model 9200), catalog number 925674325, with Impedance Respiration board... 3 11/30/2005 Smiths Medical PM, Inc.
Advisor Vital Signs Monitor (model 9200), catalog number 92D654335, with Impedance Respiration board... 3 11/30/2005 Smiths Medical PM, Inc.
Advisor Vital Signs Monitor (model 9200), catalog number 925754325, with Impedance Respiration board... 3 11/30/2005 Smiths Medical PM, Inc.
Advisor Vital Signs Monitor (model 9200), catalog number 925754225, with Impedance Respiration board... 3 11/30/2005 Smiths Medical PM, Inc.
Advisor Vital Signs Monitor (model 9200), catalog number 925754220, with Impedance Respiration board... 3 11/30/2005 Smiths Medical PM, Inc.
Advisor Vital Signs Monitor (model 9200), catalog number 920634235, with Impedance Respiration board... 3 11/30/2005 Smiths Medical PM, Inc.
Advisor Vital Signs Monitor (model 9200), catalog number 920654230, with Impedance Respiration board... 3 11/30/2005 Smiths Medical PM, Inc.
Advisor Vital Signs Monitor (model 9200), Catalog number 920654235, with Impedance Respiration board... 3 11/30/2005 Smiths Medical PM, Inc.
Advisor Vital Signs Monitor (model 9200), catalog number 920654335, with Impedance Respiration board... 3 11/30/2005 Smiths Medical PM, Inc.
Advisor Vital Signs Monitor (model 9200), catalog number 920655235, with Impedance Respiration board... 3 11/30/2005 Smiths Medical PM, Inc.
Advisor Vital Signs Monitor (model 9200), catalog number 920754235, with Impedance Respiration board... 3 11/30/2005 Smiths Medical PM, Inc.
Advisor Vital Signs Monitor (model 9200), catalog number 925454220, with Impedance Respiration board... 3 11/30/2005 Smiths Medical PM, Inc.
Advisor Vital Signs Monitor (model 9200), catalog number 925454225, with Impedance Respiration board... 3 11/30/2005 Smiths Medical PM, Inc.
Advisor Vital Signs Monitor (model 9200), catalog number 925454325, with Impedance Respiration board... 3 11/30/2005 Smiths Medical PM, Inc.
Advisor Vital Signs Monitor (model 9200), catalog number 925454335, with Impedance Respiration board... 3 11/30/2005 Smiths Medical PM, Inc.
Advisor Vital Signs Monitor (model 9200), catalog number 925474335, with Impedance Respiration board... 3 11/30/2005 Smiths Medical PM, Inc.
Advisor Vital Signs Monitor (model 9200), catalog number 925534325, with Impedance Respiration board... 3 11/30/2005 Smiths Medical PM, Inc.
Advisor Vital Signs Monitor (model 9200), catalog number 925654320, with Impedance Respiration board... 3 11/30/2005 Smiths Medical PM, Inc.
Advisor Vital Signs Monitor (model 9200), catalog number 925654335, with Impedance Respiration board... 3 11/30/2005 Smiths Medical PM, Inc.
Advisor Vital Signs Monitor (model 9200), catalog number 92D754335, with Impedance Respiration board... 3 11/30/2005 Smiths Medical PM, Inc.
Spectrum Patient Monitor, Physiological, Patient with arrhythmia detection or alamrs. Monitor can m... 3 11/23/2005 Datascope Corp
Passport 2 with View 12 ECG Analysis Module. It is a transportable, multi-parameter physiological m... 3 11/23/2005 Datascope Corp
Tru-Link DIN unshielded ECG cable, 5-lead 3 11/03/2005 Spacelabs Medical Incorporated
QUIK-COMBO pacing/defibrillation/ECG (therapy) cables used with the LIFEPAK 12 defibrillator/monitor... 2 11/02/2005 Medtronic Emergency Response Systems, Inc.
Advisor Vital Signs Monitor model 9200, catalog number 92E654335. Item Description 9200II 3LD/RP/O... 2 02/10/2005 Smiths Medical PM, Inc.
Advisor Vital Signs Monitor model 9200, catalog number 92E654325. Item Description 9200 II 3LD/RP/... 2 02/10/2005 Smiths Medical PM, Inc.
Advisor Vital Signs Monitor model 9200, catalog number 92E654220. item Description 9200 II 3LD/RSP... 2 02/10/2005 Smiths Medical PM, Inc.
Advisor Vital Signs Monitor model 9200, catalog number 925454325. Item Description 9200 II 3LD/RP/... 2 02/10/2005 Smiths Medical PM, Inc.
Advisor Vital Signs Monitor model 9200, catalog number 925474325. Item Description 9200II 3LD/RP/S... 2 02/10/2005 Smiths Medical PM, Inc.
AccessAED PAD (without ECG trace) -Public Access Defibrillator Model Number: 9100-0010-0 1 11/20/2004 Access CardioSystems
AccessAED PAD Package (without ECG trace) Model Number: 9100-0015-0 1 11/20/2004 Access CardioSystems
Esaote brand Formul@ ECG System; part 9704220000. 2 07/20/2004 Esaote Biomedica S.P.A.
Esaote brand Formula for Archimed ECG System; part 9704220000. 2 07/20/2004 Esaote Biomedica S.P.A.
Esaote brand Archimed 4220 ECG System; part 9704220000. 2 07/20/2004 Esaote Biomedica S.P.A.
Esaote brand ArchiWin Colour ECG System; part 9704325000. 2 07/20/2004 Esaote Biomedica S.P.A.
1690 Ultratrace Series ECG Electrodes, clear tape ECG electrode with wet gel. This is a single use, ... 2 08/27/2003 Conmed Corporation
1680 Invisatrace series ECG Electrodes, radiotranslucent clear tape ECG electrode with wet gel. Thi... 2 08/27/2003 Conmed Corporation
 
 
-
-