Datascope Corporation - Maquet Cardiopulmonary Bypass Custom Tubing kit - Class 3 Recall
Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-TOP 15801 Neonatal Special, Part Number 701055490 (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 7, 2018 Category: Medical Devices Source Type: alerts
Datex-Ohmeda, Inc. - CARESCAPE R860 ventilators with software version 10SP05 - Class 2 Recall
CARESCAPE R860 ventilators with software version 10SP05 Product Usage: The CARESCAPE R860 ventilator is designed to provide mechanical ventilation or support to neonatal, pediatric, and adult patients weighing 0.25 kg and above. The CARESCAPE R860 ventilator is a microprocessor based, electronically controlled, pneumatically driven ventilator that includes integrated monitoring of FiO2, airway pressure, flow, and volume. Additional respiratory gas monitoring capabilities are supported through the use of optional GE patient monitoring modules. Not all features are available for all patient types or product configurations. ...
Source: Medical Device Recalls - June 2, 2018 Category: Medical Devices Source Type: alerts
Draegar Medical Systems, Inc. - Monitor, Physiological, Patient (with Arrhythmia Detection or Alarms) - Class 2 Recall
Infinity Acute Care System (lACS) Monitoring Solution; Catalog Numbers:MS20401, MS20724, MS22956, MS25510, MS25520, MS25643, MS26196, MS26372, MS31818; UDI Information: 4049098054454, 4049098054447, 4049098054409, 4049098009799, 4049098009751. Multi-parameter, physiologic patient monitoring of adult, pediatric and neonatal patients in environments where patient care is provided by trained healthcare professionals. The lACS obtains the physiologic, multi-parameter data from the connection to the M540 monitor and optional medical devices and displays. The transfer of this data is accomplished by the Infinity network. The ...
Source: Medical Device Recalls - May 15, 2018 Category: Medical Devices Source Type: alerts
Datascope Corporation - Custom Tubing Pack with Bioline Coating - Class 2 Recall
BEQ-TOP 50900 Custom ECC Pack-Neonatal 1/4, Custom Tubing Kit, Catalog No. 709000069R02 (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 9, 2018 Category: Medical Devices Source Type: alerts
Vygon U.S.A. - Neonatal PICC Tray - Class 2 Recall
Neonatal PICC Tray, Product Code: AMS-8010CP-1 Convenience kit for the insertion of PICCs into the vascular system. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 5, 2018 Category: Medical Devices Source Type: alerts
PerkinElmer Life and Analytical Sciences, Wallac, OY - PerkinElmer Specimen Gate Screening Center - Class 2 Recall
Specimen Gate Screening Center, Part Number 5002-0500, All software versions from 1.0 to 1.8 (current software version) Specimen Gate Screening Center is used for data management of neonatal screening test results and demographics by qualified laboratory personnel in newborn screening programs. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 28, 2018 Category: Medical Devices Source Type: alerts
Draegar Medical Systems, Inc. - Infinity Acute Care System (lACS) Monitoring Solution - Class 2 Recall
Infinity Acute Care System (IACS) Monitoring Solution, Catalog Numbers: MS18841, MS20401, MS20407, MS20724, MS22956, MS25510, MS25520, MS25643, MS26196, MS26372, MS31818; UDI Information: 4049098054454, 4049098054447, 4049098054409, 4049098009799, 4049098009751 Multi-parameter, physiologic patient monitoring of adult, pediatric and neonatal patients in environments where patient care is provided by trained healthcare professsionals. The lACS obtains the physiologic, multi-parameter data from the connection to the M540 monitor and optional medical devices and displays. The transfer of this data is accomplished by the Infin...
Source: Medical Device Recalls - April 17, 2018 Category: Medical Devices Source Type: alerts
Covidien LLC - Puritan Bennett TM Ventilator System 980 Series - Class 2 Recall
Rechargeable Li-ion battery used with Puritan Bennett TM 980 Series Ventilator System including Pediatric-Adult Ventilator, Neonatal Ventilator, Universal Ventilator; Battery Product Number: 10086042; UDI: 20884521700861 The rechargeable lithium-ion batteries are intended to provide a backup power source to the ventilator in case AC power is lost. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 28, 2018 Category: Medical Devices Source Type: alerts
Centurion Medical Products Corporation - Class 2 Recall
NEONATAL IV START KIT (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 18, 2018 Category: Medical Devices Source Type: alerts
Centurion Medical Products Corporation - Class 2 Recall
NEONATAL IV ACCESS SET (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 18, 2018 Category: Medical Devices Source Type: alerts
Smiths Medical ASD Inc. - Medfusion Syringe Pump - Class 2 Recall
Medfusion Syringe Pump 4000 Series The Medfusion¿ Syringe Infusion Pumps are indicated for the following uses: 1) Administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other therapeutic fluids; 2) By the following delivery routes: arterial, epidural, intravenous, intrathecal, subcutaneous, and enteral; 3)By the following delivery modes: continuous, volume/time, mass, body weight, intermittent, and bolus; 4) In critical care, anesthesia, neonatal, and pediatric applications or other healthcare settings where use of th...
Source: Medical Device Recalls - March 6, 2018 Category: Medical Devices Source Type: alerts
Smiths Medical ASD Inc. - Medfusion Syringe Pump - Class 2 Recall
Medfusion Syringe Pump 3500 Series The Medfusion¿ Syringe Infusion Pumps are indicated for the following uses: 1) Administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other therapeutic fluids; 2) By the following delivery routes: arterial, epidural, intravenous, intrathecal, subcutaneous, and enteral; 3)By the following delivery modes: continuous, volume/time, mass, body weight, intermittent, and bolus; 4) In critical care, anesthesia, neonatal, and pediatric applications or other healthcare settings where use of th...
Source: Medical Device Recalls - March 6, 2018 Category: Medical Devices Source Type: alerts
Smiths Medical ASD Inc. - Medfusion Syringe Pump - Class 2 Recall
Medfusion Syringe Pump 3010 Series The Medfusion¿ Syringe Infusion Pumps are indicated for the following uses: 1) Administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other therapeutic fluids; 2) By the following delivery routes: arterial, epidural, intravenous, intrathecal, subcutaneous, and enteral; 3)By the following delivery modes: continuous, volume/time, mass, body weight, intermittent, and bolus; 4) In critical care, anesthesia, neonatal, and pediatric applications or other healthcare settings where use of th...
Source: Medical Device Recalls - March 6, 2018 Category: Medical Devices Source Type: alerts
Spacelabs Healthcare Inc - Spacelabs Healthcare Xhibit Telemetry Receiver, Model 96280, software version 1.1 - Class 2 Recall
Spacelabs Healthcare Xhibit Telemetry Receiver, Model 96280, software version 1.1, physiological patient monitor (with arrhythmia detection or alarms) The Spacelabs Healthcare Telemetry Receiver, Model 96280, is intended to provide the Spacelabs Healthcare monitoring system with adult, pediatric and neonatal patient data of patients connected to Spacelabs Healthcare telemetry transmitters. Data includes physiological waveforms and calculations, cardiac arrhythmia and ST data, and patient demographic information to monitor adequacy of treatment or to exclude causes of symptoms. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 26, 2018 Category: Medical Devices Source Type: alerts
Fukuda Denshi Co., Ltd. - Class 2 Recall
Fukuda Denshi patient monitor model DS-8100M and DS-8100N Product Usage: Use of the Fukuda Denshi DynaScope Model DS-8100N/8100M Patient Monitor is indicated in those situations where observation of one or more of the following parameters on an individual patient may be required. ECG (waveform, heart rate, ST-Level and ventricular arrhythmias), respiration, non-invasive blood pressure (NIBP), pulse rate, arterial oxygen saturation (SpO2), carboxyhemoglobin saturation (SpCO)*, methemoglobin saturation (SpMet)*, total hemoglobin concentration (SpHb)*, plethysmograph, temperature, invasive blood pressure (IBP), cardiac outpu...
Source: Medical Device Recalls - December 7, 2017 Category: Medical Devices Source Type: alerts
