Centurion Medical Products Corporation - NEONATAL PICC INSERTION TRAY - Class 2 Recall
NEONATAL PICC INSERTION TRAY Kit Code: CVI2310 - Product Usage: Kit is used for Peripheral Central Line Insertion procedures on newborns. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 7, 2019 Category: Medical Devices Source Type: alerts
SenTec AG - Monitor, Carbon Dioxide and Oxygen, System - Class 2 Recall
SenTec Standard Starter Set with and without Service Gas (2 changers each) - Product Usage: Is indicated for continuous, non-invasive monitoring of carbon dioxide tension and oxygen tension as well as oxygen saturation and pulse rate in adult and pediatric patients. In neonatal patients the SDMS is indicated for carbon dioxide and oxygen tension monitoring only. Oxygen tension monitoring is contraindicated for patients under gas anesthesia. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 6, 2019 Category: Medical Devices Source Type: alerts
SenTec AG - Monitor, Carbon Dioxide and Oxygen, System - Class 2 Recall
SenTec Membrane Changer (reloadable) [9 pcs] - Product Usage: Is indicated for continuous, non-invasive monitoring of carbon dioxide tension and oxygen tension as well as oxygen saturation and pulse rate in adult and pediatric patients. In neonatal patients the SDMS is indicated for carbon dioxide and oxygen tension monitoring only. Oxygen tension monitoring is contraindicated for patients under gas anesthesia. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 6, 2019 Category: Medical Devices Source Type: alerts
SenTec AG - Monitor, Carbon Dioxide and Oxygen, System - Class 2 Recall
SenTec Neonatal Starter Set with and without Service Gas (2 Chargers each) - Product Usage: is indicated for continuous, non-invasive monitoring of carbon dioxide tension and oxygen tension as well as oxygen saturation and pulse rate in adult and pediatric patients. In neonatal patients the SDMS is indicated for carbon dioxide and oxygen tension monitoring only. Oxygen tension monitoring is contraindicated for patients under gas anesthesia. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 6, 2019 Category: Medical Devices Source Type: alerts
SenTec AG - Monitor, Carbon Dioxide and Oxygen, System - Class 2 Recall
SenTec Membrane Changer Set (1 charger plus 1 insert) - Product Usage: is indicated for continuous, non-invasive monitoring of carbon dioxide tension and oxygen tension as well as oxygen saturation and pulse rate in adult and pediatric patients. In neonatal patients the SDMS is indicated for carbon dioxide and oxygen tension monitoring only. Oxygen tension monitoring is contraindicated for patients under gas anesthesia. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 6, 2019 Category: Medical Devices Source Type: alerts
SenTec AG - Monitor, Carbon Dioxide and Oxygen, System - Class 2 Recall
SenTec Membrane Changer Insert [5 pcs - Product Usage: is indicated for continuous, non-invasive monitoring of carbon dioxide tension and oxygen tension as well as oxygen saturation and pulse rate in adult and pediatric patients. In neonatal patients the SDMS is indicated for carbon dioxide and oxygen tension monitoring only. Oxygen tension monitoring is contraindicated for patients under gas anesthesia.] (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 6, 2019 Category: Medical Devices Source Type: alerts
Teleflex Medical - HUDSON RDI NEONATAL ConchaSmart Breathing Circuit - Class 1 Recall
HUDSON RDI NEONATAL ConchaSmart Breathing Circuit with Dual Heated Limb and ConchaSmart Column: a) REF 870-07KIT b) REF 870-09KIT Product Usage: The proposed Neonatal ConchaSmart breathing circuits are intended to deliver humidified breathing gases for administration to an infant/neonate patient. Gases available for medical use do not contain sufficient moisture and may damage or irritate the respiratory tract, or desiccate secretions of patients whose supraglottic airways have been bypassed. Thus humidified gases via heated breathing circuit may be indicated for patients requiring mechanical ventilation, positive pressur...
Source: Medical Device Recalls - July 16, 2019 Category: Medical Devices Source Type: alerts
Hamilton Medical AG - Hamilton G5 Ventilator - Class 1 Recall
HAMILTON-G5, with software versions less than or equal to 2.60 The HAMILTON-G5/S1 ventilators are designed for intensive care ventilation of adult and pediatric patients, and optionally infant and neonatal patients. The device is intended for use in the hospital and institutional environment where health care professionals provide patient care. (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 12, 2019 Category: Medical Devices Source Type: alerts
GE Healthcare, LLC - ECG Trunk Cable - Class 3 Recall
ECG Trunk Cables: REF/Catalog Number Description 2106305-001 ECG Trunk Cable, 3/5-lead, AHA, 3.6 m/12 ft. 2106305-002 ECG Trunk Cable, 3/5-lead, AHA, 1.2 m/4 ft. 2106305-003 ECG Trunk Cable, 3/5-lead, IEC, 3.6 m/12 ft. 2106305-004 ECG Trunk Cable, 3/5-lead, IEC, 1.2 m/4 ft. 2106306-001 ECG Trunk Cable, Neonatal, DIN 3-lead, AHA, 3.6 m/12 ft. 2106306-002 ECG Trunk Cable, Neonatal, DIN 3-lead, AHA, 1.2 m/4 ft. 2106306-003 ECG Trunk Cable, Neonatal, DIN 3-lead, IEC, 3.6 m/12 ft. 2106306-004 ECG Trunk Cable, Neonatal, DIN 3-lead, IEC, 1.2 m/4 ft. 2106307-001 ECG Trunk Cable, 6-lead, AHA, 3.6 m/12 ft. 2106307-002 ECG Trunk Cab...
Source: Medical Device Recalls - June 26, 2019 Category: Medical Devices Source Type: alerts
Maquet Cardiovascular, LLC - Class 2 Recall
Maquet Getinge-BEQ-TOP 2202 NEONATAL SPECIALT Material:701062613 (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 1, 2019 Category: Medical Devices Source Type: alerts
Maquet Cardiovascular, LLC - Class 2 Recall
Maquet Getinge-BEQ-TOP 50900 Custom ECC Pack-Neonatal ¿ Material: 709000069R02 (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 1, 2019 Category: Medical Devices Source Type: alerts
Bard Medical Division - ARCTIC SUN ARCTICGEL Pads - Class 2 Recall
Medivance(R) ARCTIC SUN(R) ARCTICGEL(TM) Pads: Description, Catalog Number a) Intrepid ArcticGel Small Pad Kit, 31705I b) Intrepid ArcticGel Medium Pad Kit, 31707I c) Intrepid ArcticGel Large Pad Kit, 31709I d) Intrepid ArcticGel Universal Pad, 31700I e) ArcticGel Universal Pad, 31700 f) ArcticGel Universal Pad, 4-pack, 3170004 g) ArcticGel X-Small Pad, 31703 h) ArcticGel X-Small Pad, 2-pack, 3170302 i) ArcticGel Small Pad Kit, 31705 j) ArcticGel Small Pad Kit, 2-pack, 3170502 k) ArcticGel Medium Pad Kit, 31707 l) ArcticGel Medium Pad Kit, 2-pack, 3170702 m) ArcticGel Large Pad Kit, 31709 n) ArcticGel Large Pad Kit, 2-pack...
Source: Medical Device Recalls - April 28, 2019 Category: Medical Devices Source Type: alerts
Draegar Medical Systems, Inc. - Delta, Delta XL, Kappa - Class 2 Recall
Infinity Delta Family patient monitors The Infinity Delta Series (Delta/Delta XL/Kappa) monitors are intended to be used on adult, pediatric, and neonatal populations, with the exception of the parameter Cardiac Output, ST Segment Analysis, and arrhythmia which are intended for use in the adult and pediatric populations only; and tcp02, which for the neonatal population, is to only be used when the patient is not under gas anesthesia.-Omega and Omega S are intended to be used on adult, pediatric, and neonatal populations. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 6, 2019 Category: Medical Devices Source Type: alerts
GE Healthcare, LLC - GE HEALTHCARE LOGIQ P6 Premium - Class 2 Recall
GE HEALTHCARE LOGIQ P6 Premium TruScan(TM) Imagining Technology: (a) Model BT09 (b) Model BT07 Product Usage: The device is intended for use by a qualified physician for ultrasound evaluation of Fetal; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric). Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transrectal; Transvaginal; and Intraoperative (abdominal, thoracic, vascular). (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 31, 2019 Category: Medical Devices Source Type: alerts
Agfa-Gevaert, N.V. - Agfa DXD 600 - Class 2 Recall
DX-D 600 DIRECT RADIOGRAPHY SYSTEM Product Usage: The DX-D 600 system is a ceiling mounted General Radiography X-Ray imaging system used in hospitals, clinics and medical practices by physicists, radiographers and radiologists to make, process and view static X-Ray radiographic images of the skeleton (including skull, spinal column and extremities), chest, abdomen and other body parts on adult, pediatric or neonatal patients. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 8, 2019 Category: Medical Devices Source Type: alerts
