DeRoyal Industries Inc - HYDROTEMP(R) Neonatal Temperature Skin Sensor - Class 2 Recall
HYDRO-TEMP(R) Neonatal Temperature Skin Sensor, REF HNICU-32, 50 units per box, NON STERILE, Rx only. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 1, 2015 Category: Medical Equipment Source Type: alerts
Utah Medical Products, Inc - MyeloNate CSF Sampling Kit - Class 2 Recall
Myelo-Nate CSF Sampling Kit, Neonatal/Pediatric cerebralspinal fluid sampling sterile tray, including a lumbar puncture needle, four collection vials, an iodine swabstick package, a fenestrated drape, a polylined drape, three gauze pads, and one spot bandage. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 7, 2015 Category: Medical Equipment Source Type: alerts
Hamilton Medical, Inc. - Continuous Ventilator - Class 1 Recall
HAMILTON-G5 Ventilator with software versions between V2.00 and V2.31. Anesthesiology: The HAMILTON-G5 ventilator is designed for intensive care ventilation of adult and pediatric patients, and optionally infant and neonatal patients (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 5, 2015 Category: Medical Equipment Source Type: alerts
Perkin Elmer Life Sciences Inc - Specimen Gate Screenig Center - Class 2 Recall
Perkin Elmer Specimen Gate, Screening Center. 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 - October 27, 2015 Category: Medical Equipment Source Type: alerts
Natus Medical Incorporated - Natus neoBLUE 3 Phototherapy system - Class 2 Recall
Natus neoBLUE 3 Phototherapy system or Neonatal Phototherapy, Catalogue Part Number: 010066; Top Assembly Part Number: 001103 (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 22, 2015 Category: Medical Equipment Source Type: alerts
Covidien LP (formerly Nellcor Puritan Bennett Inc.) - Puritan Bennett 980 Ventilator System Universal and Neonatal Models - Class 1 Recall
Puritan Bennett 980 Ventilator System, Universal (with neonatal functionality enabled) and Neonatal Models. Designed for use on Neonatal (NICU) through Adult patient populations who require respiratory support or mechanical ventilation and weigh a minimum of 0.3 kg (0.66 lb). (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 15, 2015 Category: Medical Equipment Source Type: alerts
Draeger Medical, Inc. - PS500 of an IACS Workstation Critical Care (Evita Infinity V500) - Class 1 Recall
PS500 of an IACS Workstation Critical Care (Evita Infinity V500); intended for the ventilation of adult, pediatric and neonatal patients. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 15, 2015 Category: Medical Equipment Source Type: alerts
Siemens Medical Solutions USA, Inc. - ACUSON S Family ultrasound systems - Class 2 Recall
ACUSON S Family ultrasound systems utilizing the 18L6 HD and/or 6C1 HD biopsy guidelines 6C1HD - model numbers: 10442008 6C1HD Needle Guide, S3000; 10440586 6C1 HD Biopsy Guide, S2000 18L6 - model numbers: 10442007 18L6 Biopsy Guide, S3000 10044200 S2000 Biopsy Starter Kit, 18L6 HD 10855189 18L6 HD Biopsy Starter Kit, S1000 Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular app...
Source: Medical Device Recalls - August 6, 2015 Category: Medical Equipment Source Type: alerts
Siemens Medical Solutions USA, Inc. - ACUSON S2000 and ACUSON S3000 ultrasound systems - Class 2 Recall
ACUSON S2000 and ACUSON S3000 ultrasound systems with the Virtual Touch IQ option; Model numbers: 10041461, 10440017 -S2000 system 10441730 -S3000 system VTIQ Option- 10439521 and 10439522 Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications. (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 31, 2015 Category: Medical Equipment Source Type: alerts
Siemens Medical Solutions USA, Inc. - ACUSON S 1000, ACUSON S 2000, or ACUSON S 3000 ultrasound systems. - Class 2 Recall
ACUSON S 1000, ACUSON S 2000, or ACUSON S 3000 ultrasound systems with software version C3, C3, C3, or C1. Model numbers: 10041461, 10440017 S 2000 system 10441730 S 3000 system 10441701 S 1000 system Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications. (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 30, 2015 Category: Medical Equipment Source Type: alerts
Covidien LP (formerly Nellcor Puritan Bennett Inc.) - OxiMax N65 Handheld Pulse Oximeter - Class 2 Recall
OxiMax¿ N-65 Handheld Pulse Oximeter Product Usage: The Nellcor OxiMax¿ N-65 Handheld Pulse Oximeter is indicated for continuous or spot check monitor of functional arterial oxygen saturation (SpO2) and pulse rate of adult, pediatric and neonatal patients in hospital, hospital type facilities, transport and mobile environments as wells as in the home care environment. (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 28, 2015 Category: Medical Equipment Source Type: alerts
Covidien LP (formerly Nellcor Puritan Bennett Inc.) - OxiMax N560 Pulse Oximeter - Class 2 Recall
OxiMax N-560 Pulse Oximeter Product Usage: The Nellcor OxiMax¿ N-65 Handheld Pulse Oximeter is indicated for continuous or spot check monitor of functional arterial oxygen saturation (SpO2) and pulse rate of adult, pediatric and neonatal patients in hospital, hospital type facilities, transport and mobile environments as wells as in the home care environment. (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 28, 2015 Category: Medical Equipment Source Type: alerts
Maquet Cardiovascular Us Sales, Llc - FLOWi - Class 2 Recall
The FLOW-i Anesthesia System Axillary O2 and Suction Module, Device Part number: 66 79 847 FLOW-i Anesthesia System: Is indicated for administering inhalation anesthesia while controlling the entire ventilation of patients with no ability to breathe, as well as in supporting patients with a limited ability to breathe.The system is intended for use in a wide range of population: from neonatal to adult patients. The system is intended for use in hospital environments, except for the MRI environment, by healthcare professionals trained in inhalation anesthesia administration. Auxiliary O2 and Suction Module: Is an option av...
Source: Medical Device Recalls - July 16, 2015 Category: Medical Equipment Source Type: alerts
Hamilton Medical, Inc. - HamiltonG5 - Class 1 Recall
Hamilton-G5 Ventilators with software versions V2.40/2.41 Catalog numbers for G5: 159001 and 159002. Software: 159700.. Intensive care ventilation of adult and pediatric patients and optionally infant and neonatal patients. (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 11, 2015 Category: Medical Equipment Source Type: alerts
Hamilton Medical, Inc. - HamiltonG5 - Class 2 Recall
Hamilton-G5 Ventilators with software versions V2.40/2.41 Catalog numbers for G5: 159001 and 159002. Software: 159700.. Intensive care ventilation of adult and pediatric patients and optionally infant and neonatal patients. (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 11, 2015 Category: Medical Equipment Source Type: alerts
