Draeger Medical, Inc. - Draegar - Class 2 Recall
Evita V500 Ventilator with Software 2.51.01 and Lower - intended for the ventilation of adult, pediatric and neonatal patients Catalog Number: 8416400 (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 5, 2022 Category: Medical Devices Source Type: alerts
Siemens Medical Solutions USA, Inc. - ACUSON Juniper Diagnostic Ultrasound System - Class 2 Recall
Diagnostic Ultrasound System, ACUSON Juniper, UDI: (01)04056869152059, Model: 11335791, Rx, CE Ultrasound imaging system intended for the following applications: Vascular, Abdominal, Neonatal, Echocardiographical, Pediatric, Small Parts, Musculoskeletal, Obstetrical, Gyneological, Intraoperative, and Urological applications using different ultrasound transducers for different applications. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 12, 2022 Category: Medical Devices Source Type: alerts
Vyaire Medical - bellavista - Class 1 Recall
bellavista 1000 ventilator, Catalog #301.100.030 and bellavista 1000e ventilator, 301.100.130. The bellavista 1000/1000e ventilator is intended to provide positive pressure ventilatory support to adult and pediatric patients, and optionally, infant and neonatal patients. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 17, 2022 Category: Medical Devices Source Type: alerts
Draeger Medical, Inc. - Class 2 Recall
Babylog VN500 Ventilator with Installed CO2 Measurement Option-intended for the ventilation of neonatal patients from 0.4 kg (0.88 lbs) up to 10 kg (22 lbs) and pediatric patients from 5 kg (11 lbs) up to 20 kg (44 lbs) bodyweight. Catalog Number: 8417400 (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 15, 2021 Category: Medical Devices Source Type: alerts
Draeger Medical, Inc. - Class 2 Recall
Evita V500 Ventilator with Installed CO2 Measurement Option-Intended for the ventilation of adult,pediatric and neonatal patients. Catalog Number: 8416400 (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 15, 2021 Category: Medical Devices Source Type: alerts
NIHON KOHDEN ORANGEMED, INC - Nihon Kohden NKV550 Ventilator System - Class 2 Recall
Nihon Kohden NKV-550 Ventilator, REF: NKV-550-U, CE 0344, UDI: (01) 00843685100012 The Nihon Kohden NKV-550 Series Ventilator System is intended to provide continuous ventilation for adult, pediatric and neonatal patients who require invasive or noninvasive respiratory support. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 9, 2021 Category: Medical Devices Source Type: alerts
Mediana Co., Ltd. - Vital Signs Monitor - Class 2 Recall
AVSM3 SNF, Vital Signs Monitor The monitor is intended to be used to monitor noninvasive blood pressure (NIBP), functional arterial oxygen saturation (SpO2), pulse rate (PR), temperature (Temp) for adult, pediatric and neonatal patients in all areas of a hospital and hospital-type facilities. (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 20, 2021 Category: Medical Devices Source Type: alerts
Medtronic Perfusion Systems - Medtronic 1A46R11, Custom Pack 1A46R11 Neonatal - Class 2 Recall
Medtronic 1A46R11, Custom Pack 1A46R11 Neonatal, Custom Perfusion System, Sterile, Rx. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 17, 2021 Category: Medical Devices Source Type: alerts
Hitachi Medical Systems America Inc - ALOKA ARIETTA 850SE - Class 2 Recall
Ultrasonic pulsed doppler imaging system - Product Usage: intended for use by trained personnel (doctor, Sonographer, etc.) for the diagnostic ultrasound evaluation of Fetal, Abdominal, Intra-operative (Spec.), Intraoperative (Neuro.), Laparoscopic, Pediatric, Small Organ (Spec.), Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Trans-esoph. (non-Card.), Musculo-skel. (Convent.), Musculo-skel. (Superfic.), Wound (Cavernous/Non-Cavernous), Gynecology, Cardiac Adult, Cardiac Pediatric, Trans-esophageal (card.), Peripheral vessel, Endoscopy clinical applications. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 20, 2021 Category: Medical Devices Source Type: alerts
Smiths Medical ASD Inc. - Bivona Cuffless Neonatal/Pediatric FlexTend Tracheostomy Tube - Class 2 Recall
Tube Tracheostomy and Tube Cuff, Bivona¿ Cuffless Neonatal/Pediatric FlexTend" Tracheostomy Tube (model 60PFS45, lots 3991171, 3991172, and 3988103) V Neck Flange 4.5mm - Product Usage: intended to provide direct airway access for a tracheotomized patient for up to 29 days. It may be reprocessed for single-patient use up to 5 times. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 24, 2021 Category: Medical Devices Source Type: alerts
Medtronic Neurosurgery - Medtronic Delta CSFFlow Control Valves and Shunts - Class 2 Recall
Medtronic Delta CSF (Cerebro Spinal Fluid) -Flow Control Valves for the following CFNs/REF numbers: 24048 - VALVE 24048 DELTA RGL PL 0.5, 24053 - CHAMBER 24053 DELTA, 24147 - VALVE 24147 DELTA SML PL0.5, 25121-1 - ASSY 25121-1 DELTA SML SNAP PERIT 120, 25121-5 - ASSY 25121-5 DELTA SML SNAP P-CATH 120, 25131-1 - DELTA 25131-1 INTL ONLY SHUNT SM 1.0, 25131-2 - SHUNT 25131-2 INTL ONLY DELTA SM 2.0, 25131-5 - SHUNT 25131-5 INTL ONLY DELTA SM 1.5, 25132-2 - SHUNT 25132-2 INTL ONLY DELTA REG.2.0, 25132-5 - SHUNT 25132-5 INTL ONLY DELTA REG 1.5, 27219-1 - VALVE 27219-1 NEONATE DELTA, 27219-2 - VALVE 27219-2 NEONATE DELTA, 27219-...
Source: Medical Device Recalls - February 13, 2021 Category: Medical Devices Source Type: alerts
Draegar Medical Systems, Inc. - The Infinity Acute Care System (IACS) Standalone Infinity M540 patient monitor - Class 2 Recall
Infinity Acute Care System (IACS) Monitoring Solution: The IACS is intended for multi-parameter, physiologic patient monitoring of adult, pediatric and neonatal patients in environments where patient care is provided by trained healthcare professionals. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 11, 2021 Category: Medical Devices Source Type: alerts
Medtronic Neurosurgery - Delta Neonatal Valves - Class 2 Recall
REF 27219-5 X1, Medtronic, Delta Valve, Neonatal, Performance Level 1.5, CE 0344, Sterile EO - Product Usage: Neonatal Delta Snap Shunt Assemblies are components of CSF-Flow Control Shunt Systems designed to provide controlled CSF flow from the ventricles of the brain into the peritoneal cavity. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 16, 2021 Category: Medical Devices Source Type: alerts
Medtronic Neurosurgery - Delta Neonatal Valves - Class 2 Recall
REF 27219-1 X1, Medtronic, Delta Valve, Neonatal, Performance Level 1.0, CE 0344, Sterile EO - Product Usage: Neonatal Delta Snap Shunt Assemblies are components of CSF-Flow Control Shunt Systems designed to provide controlled CSF flow from the ventricles of the brain into the peritoneal cavity. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 16, 2021 Category: Medical Devices Source Type: alerts
Medtronic Neurosurgery - Delta Neonatal Valves - Class 2 Recall
REF 27219-2 X1, Medtronic, Delta Valve, Neonatal, Performance Level 2.0, CE 0344, Sterile EO - Product Usage: Neonatal Delta Snap Shunt Assemblies are components of CSF-Flow Control Shunt Systems designed to provide controlled CSF flow from the ventricles of the brain into the peritoneal cavity. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 16, 2021 Category: Medical Devices Source Type: alerts
