Siemens Healthcare Diagnostics, Inc. - ADVIA Centaur XPT Immunoassay System - Class 2 Recall
ADVIA¿ Centaur XPT system software versions V1.0.1 (Bundle 1.0.912 SMN 10819704), V1.0.2 (Bundle 1.0.1086 SMN 11219806), V1.0.3 (Bundle 1.0.1108 SMN 11220781) and V1.1 (Bundle 1.1.243 SMN 11221979). Product Usage: This system is intended for professional use in a laboratory environment only. Tests performed using this system are intended for in vitro diagnostic use. As with all diagnostic tests, a definitive clinical diagnosis should not be based on the results of a single test, but should only be made by the physician after all clinical and laboratory findings have been evaluated. (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 22, 2016 Category: Medical Equipment Source Type: alerts
Physio-Control, Inc. - LIFEPAK15 monitor/defibrillator - Class 2 Recall
LIFEPAK15 monitor/defibrillator with End-Tidal C02 (EtC02) feature installed. Part numbers: V15-2-xxxxxx (includes software version 1 and version 2); V15-5-xxxxxx (inclues software version 4). The LIFEPAK 15 monitor/defibrillator is intended for use by trained medical personnel in outdoor and indoor emergency care settings within the environmental conditions specified. The LIFEPAK 15 monitor/defibrillator is designed to be used during ground transportation except when specified otherwise. Manual mode monitoring and therapy functions are intended for use on adult and pediatric patients. Automated external defibrill...
Source: Medical Device Recalls - June 16, 2016 Category: Medical Equipment Source Type: alerts
Stryker Medical Division of Stryker Corporation - PowerPRO XT, PowerPRO IT, PowerPRO TL - Class 2 Recall
Stryker PowerPRO (XT, IT, or TL) Cots Stretcher, Wheeled The Stryker Power-PRO" are powered ambulance cots are designed to support and transport a maximum weight of 700 lb. (318 kg) in pre-hospital and hospital environments. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 15, 2016 Category: Medical Equipment Source Type: alerts
Medtronic - Battery Pack - Class 1 Recall
Battery Pack Used with the Capnostream"20 and Capnostream"20p Patient Monitor, Battery Packs Model Number - 016400, 010520. Battery Pack used with the Capnostream"20 and Capnostream"20p Patient Monitor. The battery pack powers the monitor when AC power is not available or when monitoring is required during intra-hospital transfer of patients. The Capnostream"20 and Capnostream"20p is a combined capnograph/pulse oximeter monitor and its accessories are intended to provide professionally trained health care providers with continuous, non-invasive measurement and monitoring of carbon dioxide con...
Source: Medical Device Recalls - May 13, 2016 Category: Medical Equipment Source Type: alerts
Hamilton Medical, Inc. - Hamilton G5 with software version between v2.41, v2.42, v2.50. - Class 2 Recall
Hamilton G5 with software version between v2.41, v2.42, v2.50. Catalog number: 1590001 and 1590002. Anesthesiology: Hamilton G5 ventilator is designed for intensive care ventilation of adult and pediatric patients, and optionally infants 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 - May 10, 2016 Category: Medical Equipment Source Type: alerts
Siemens Healthcare Diagnostics, Inc. - ADVIA Centaur CP - Class 3 Recall
ADVIA Centaur CP Immunoassay System, Siemens Material Number (SMN) 10309710, IVD. --- CLASSIFICATION NAME: Immunoassay Analyzers. This system is intended for professional use in a laboratory environment only. Tests performed using this system are intended for in vitro diagnostic use. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 7, 2016 Category: Medical Equipment Source Type: alerts
Arjo, Inc. dba ArjoHuntleigh - ArjoHuntleigh Inc. - Class 2 Recall
The Concerto Basic Shower Trolley is intended for assisted hygiene care, especially showering and bathing of residents in care environments such as senior/assisted living, group home, special care, nursing homes, hospitals and home care. The Concerto Basic Shower Trolley is intended for indoor use. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 15, 2016 Category: Medical Equipment Source Type: alerts
Intuitive Surgical, Inc. - da Vinci S Surgical System - Class 2 Recall
da Vinci S Surgical System (IS1200/IS2000/IS3000) user manual, instrument & accessory. Product Usage: The Intuitive Surgical Endoscopic Instrument Control System is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, ultrasonic shears, forceps/pick-ups, needle holders, endoscopic retractors, stabilizers, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery an...
Source: Medical Device Recalls - April 13, 2016 Category: Medical Equipment Source Type: alerts
Intuitive Surgical, Inc. - da Vinci S Surgical System - Class 2 Recall
da Vinci S Surgical System (IS4000) user manual English and OUS. Product Usage: The Intuitive Surgical Endoscope Instrument Control System (da Vinci Surgical System, Model IS4000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximations, ligation, electrocautery, suturing and delivery and placement of mic...
Source: Medical Device Recalls - April 13, 2016 Category: Medical Equipment Source Type: alerts
GE Medical Systems, LLC - GE SIGNA Pioneer - Class 2 Recall
SIGNA Pioneer MR Systems Product Usage: The SIGNA Pioneer is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. It is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images, spectroscopic images, parametric maps, and/or spectra, dynamic images of the structures and/or functions of the entire body, including, but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. Depending on the region of interest bein...
Source: Medical Device Recalls - April 8, 2016 Category: Medical Equipment Source Type: alerts
Maquet Cardiovascular Us Sales, Llc - Maquet Flowi - Class 1 Recall
Flow-i Anesthesia System Product Usage: The indication for the Flow-i Anesthesia System is administering inhalation anesthesia while controlling the entire ventilation of patients with no ability to breath, as well as in supporting patients with a limited ability to breath. The system is intended for use on neonatal to adult patient populations. The system is intended for use in hospital environments, except MRI environment by healthcare professionals trained in inhalation anesthesia administration. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 23, 2016 Category: Medical Equipment Source Type: alerts
Salter Labs - Tpiece Nebulizer with inline connectors - Class 2 Recall
T-piece Nebulizer with in-line connectors, Part number 8915-7-50. Single patient use, non-sterile prescription device designed for use in a hospital or home care environment. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 11, 2016 Category: Medical Equipment Source Type: alerts
PRO1TEK ANTISEPTIC HAND SANITIZER (Benzalkonium Chloride) Aerosol, Foam [Priority Environmental Solutions, Inc.]
Updated Date: Jan 28, 2016 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - January 28, 2016 Category: Drugs & Pharmacology Source Type: alerts
GE Medical Systems, LLC - GE Healthcare, Aisys CS2; Avance Amingo,, &38; Avance CS2 - Class 2 Recall
GE Healthcare, Aisys CS2,1011-9050-000; Avance Amingo,1009-9002-000, & Avance CS2, 1009-9050-000. The GE Datex-Ohmeda Aisys Anesthesia System is intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (neonatal, pediatric, adult). The device is intended for volume or pressure control ventilation. The Aisys is not suitable for use in a MRI environment. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 22, 2016 Category: Medical Equipment Source Type: alerts
