Merge Healthcare, Inc. - Merge Hemo Software Versions: 9.10, 9.20.0, 9.20.2, 9.30.0, 9.40.0, 9.40.1, 9.40.2 with Windows 7 OS - Class 2 Recall
Merge Hemo software. Merge Hemo monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure. The Monitoring System is for the monitoring of vital parameters including ECG, SpO2, invasive blood pressure, temperature, NIBP and CO2, and for the evaluation of resting ECG, arrhythmias, ST-segments and cardiac output. Some systems are built and designed to measure End Tidal CO2. The system is intended for use in hospital cardiac catheterization laboratories (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 29, 2016 Category: Medical Equipment Source Type: alerts
ICU Medical, Inc. - Transpac IV Monitoring Kit - Class 2 Recall
CARDIAC CATHETERIZATION WASTE MANAGEMENT SYSTEM LEFT HEART KIT, Item No. 46073-14 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 16, 2016 Category: Medical Equipment Source Type: alerts
ICU Medical, Inc. - Transpac IV Monitoring Kit - Class 2 Recall
Cardiac Catheterization Right Heart Kit w/2-Station, Right Hand, On, High Pressure Manifold and Transpac¿ IV Disposable Transducer, Item No. 46083-03 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is require...
Source: Medical Device Recalls - November 16, 2016 Category: Medical Equipment Source Type: alerts
Merge Healthcare, Inc. - Merge Hemo with software versions 10.0 LA - Class 2 Recall
Merge Hemo with software versions 10.0 LA. Merge Hemo (formerly named HeartSuite Hemodynamics) monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 29, 2015 Category: Medical Equipment Source Type: alerts
Arrow International Inc - Class 2 Recall
ARROW PICC Kit featuring Chlorag+ard Technology Midline Catheterization Kit ARROW Advantage5 Pressure Injectable PICC Kit Arrow¿ Pressure Injectable Arrow¿ PICC powered by Arrow¿ VPS¿ Stylet ARROW Pressure Injectable JACC with Chlorag+ard Technology For short-term or long-term peripheral access to the central venous system for intravenous therapy, blood sampling, infusion, pressure injection of contrast media, and allows for central venous pressure monitoring. Permits venous access to the peripheral circulation. Offers an alternative method of intravenous access for select adult and pediatric patie...
Source: Medical Device Recalls - November 5, 2015 Category: Medical Equipment Source Type: alerts
Merge Healthcare, Inc. - Merge Hemo - Class 2 Recall
Merge Hemo, 9.10, 9.20.0, 9.20.1,9.20.2, 9.30, 9.40.0, 9.40.1, 9.40.2 with Massimo PHASEIN End Tidal CO2 (EtCO2) module Merge Hemo (formerly named HeartSuite Hemodynamics) monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure. The Monitoring System is for the monitoring of vital parameters including ECG, SpO2, invasive blood pressure, temperature, NIBP and CO2, and for the evaluation of resting ECG, arrhythmias, ST-segments and cardiac output. Some systems are built and designed to measure End Tidal CO2. The system comprises the Patient Data Module and the Mer...
Source: Medical Device Recalls - August 7, 2015 Category: Medical Equipment Source Type: alerts
Arrow International Inc - Arrow MultiLumen Central Venous Catheterization - Class 2 Recall
Multi-Lumen Central Venous Catheterization Kit (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 17, 2014 Category: Medical Equipment Source Type: alerts
AGFA Corp. - IMPAX CV Pediatric Echo Reporting, IMPAX CV Echo Measurement Import via Optical Character Recognitio - Class 2 Recall
IMPAX CV Pediatric Echo Reporting, IMPAX CV Echo Measurement Import via Optical Character Recognition (OCR) Service IMPAX. The IMPAX CV Reporting component facilitates the quick effective creation of digital structured reports for adult catheterization and echocardiography, pediatric echocardiography, congenital heart disease, nuclear cardiology and non-invasive vascular disease management. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 28, 2014 Category: Medical Equipment Source Type: alerts
Baylis Medical Corp * - TorFlex - Class 1 Recall
Baylis Medical TorFlex Transseptal Guiding Sheath, Rx Only, non-pyrogenic, sterile. Product Usage: The TorFlex Transseptal Guiding Sheath kit (K102948) is a single use device consisting of three components: a sheath, a dilator, and a J-tipped guidewire. The kit is designed for safe and easy catheterization and angiography of specific heart chambers and locations. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 2, 2013 Category: Medical Equipment Source Type: alerts
AGFA Corp. - IMPAX CV 7.8 SU3 OCR Service - Class 2 Recall
IMPAX CV 7.8 SU3 - OCR Service. The IMPAX CV Reporting component facilitates the quick , effective creation of digital structured reports for adult catheterization and echocardiography, pediatric echocardiography, congenital heart disease, nuclear cardiology and non-invasive vascular disease management. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 9, 2013 Category: Medical Equipment Source Type: alerts
AGFA Corp. - IMPAX CV Reporting Cardiac Catheterization module and IMPAX CV Outbound Reporting - Class 2 Recall
IMPAX CV Reporting Cardiac Catheterization module and IMPAX CV Outbound Reporting. Facilitates digital reports for catheterization, echocardiography, and congenital heart disease. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 9, 2013 Category: Medical Equipment Source Type: alerts
Arrow International Inc - Teleflex Medical Berman Angiographic Balloon Catheter and Reverse Berman Angiographic Balloon Cathet - Class 2 Recall
Arrow/Teleflex Medical Berman Angiographic Balloon Catheter and Reverse Berman Angiographic Balloon Catheter. The Arrow Berman(TM) Angiographic Catheter is indicated for use in right heart catheterization for cardiac angiography, and measurement of the right heart and pulmonary artery pressures. It can be sued to inject radiopaque media and measure pressures in any chamber or vessel that can be entered from the right heart. The Arrow Berman(TM) Angiographic Catheter is also indicated for use in Balloon Occlusion Femoral Angiography (BOFA) of the ipsilateral leg for adult patients. The Arrow Reverse Berman(TM) Angiograph...
Source: Medical Device Recalls - April 5, 2013 Category: Medical Equipment Source Type: alerts
