200 results · 19ms · Sources: EU EUDAMED, US FDA

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GE Datex-Ohmeda Advance Anesthesia Gas-Machine.

FDA Recall
Terminated ·GE Healthcare·Product code BSZ·February 5, 2009

Mindray A5 Anesthesia Delivery System Manufactured in China for Mindray DS USA Inc. 800 MacArthur Boulevard, Mahwah, NJ 07430 This is a device used to administer to a patient continuously or intermittently a general inhalation anesthetic and to maintain a patient's ventilation.

FDA Recall
Terminated ·Mindray DS USA, Inc. d.b.a. Mindray North America·Product code BSZ·August 13, 2012

Newport Portable Package, Model #50000, Serial # 13591, 13592, 13604, 13606, 13614, 13662, 13663, 13664, 13726, 13731, 13733, 13736, 13737, 13738, 13740, 13768, 13770, 13771, 13772, 13784, 13787. Product Usage: Portable Analgesia Gas Machine.

FDA Recall
Terminated ·Accutron Inc·Product code BSZ·April 29, 2012

CM Flowmeter Pkg H, Model #36700, Serial # 13749 Product Usage: Conscious Sedation Unit Analgesia Gas Machine.

FDA Recall
Terminated ·Accutron Inc·Product code BSZ·April 29, 2012

GE Healthcare, Avance, Avance CS2, Aisys, Aespire View, and Engstrom. Intended for volume or pressure control ventilation.

FDA Recall
Terminated ·GE Healthcare, LLC·Product code BSZ·August 28, 2013

McKesson Anesthesia Care Product Usage: The McKesson Anesthesia Care system is a computer based system which collects, processes,and records data both through manual entry and from monitors which themselves are attached to patients, such as in the operating room environment. The system provides clinical decision support by communicating potential Adverse Drug Event alerts proactively during the pre-anesthesia evaluation and at the point-of-care. The system is generally indicated in the anesthetizing environment when the anesthesia provider decides to perform a patient assessment, to generate a paper and/or electronic record of the administration of anesthesia to a patient, and to document care.

FDA Recall
Terminated ·MCKESSON TECHNOLOGIES INC.·Product code BSZ·March 15, 2013

GE Datex-Ohmeda ADU Carestation Intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients.

FDA Recall
Terminated ·GE Healthcare·Product code BSZ·October 30, 2008

Datex-Ohmeda S/5 Aespire Anesthesia System 7100

FDA Recall
Terminated ·Datex-Ohmeda Inc·Product code BSZ·September 27, 2005

GE, 1011-9000-000 Aisys Anesthesia Machine and Monitor

FDA Recall
Terminated ·Ge Healthcare, Llc·Product code BSZ·March 12, 2010

FLOW-i Anesthesia System The FLOW-i Anesthesia System is intended for use administering inhalation anesthesia on neonatal to adult patient populations.

FDA Recall
Terminated ·Maquet Cardiovascular Us Sales, Llc·Product code BSZ·April 2, 2015

GE Healthcare, Aisys, 1011-9000-000. 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.

FDA Recall
Terminated ·GE Medical Systems, LLC·Product code BSZ·December 15, 2015

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.

FDA Recall
Terminated ·GE Medical Systems, LLC·Product code BSZ·December 15, 2015

Flow-i C40 Anesthesia System, model 6677400

FDA Recall
Open, Classified ·Getinge Usa Sales Inc·Product code BSZ·December 11, 2023

Vaporizer Sevoflurane Maquet Filling, Product code/REF number (6682282), Component of: Flow-i C20, Flow-i C30,Flow-i C40, Flow-c, Flow-e.

FDA Recall
Open, Classified ·Getinge Usa Sales Inc·Product code BSZ·May 1, 2024

UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System, Catalog No. 775222 UniCel DxH Slidemaker Stainer (DxH SMS) Instructions for Use (IFU) Part Number B26647AC The DxH Slidemaker Stainer is a fully automated slide preparation and staining device that aspirates a whole-blood sample, smears a blood film on a clean microscope slide, and delivers a variety of fixatives, stains, buffers, and rinse solutions to that blood smear

FDA Recall
Terminated ·Beckman Coulter Inc.·Product code BSZ·August 4, 2016

A-Series A3/A5 Anesthesia Delivery System; Model Numbers: 0633F-01000-0X (A3) and 0631F-01000-0X (A5) Product Usage: The A-Series Anesthesia System is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic, and to maintain a patient s ventilation. The A-Series is intended for use by licensed clinicians, for patients requiring anesthesia within a health care facility, and can be used for adult, pediatric, and infant populations.

FDA Recall
Terminated ·Mindray DS USA, Inc. dba Mindray North America·Product code BSZ·July 14, 2017

GE Carestation 620/650/650c, A1 and A2 (non-US distribution) anesthesia systems

FDA Recall
Terminated ·GE Medical Systems China Co., Ltd. National Hi-Tech No.·Product code BSZ·July 24, 2018

9100c NXT system - Product Usage: Device is licensed and distributed outside of the US only.

FDA Recall
Open, Classified ·GE Healthcare, LLC·Product code BSZ·September 17, 2020

GE Healthcare Avance CS2, Avance CS2 Pro Anesthesia Systems, Part #1009-9050-000; and Aisys CS2 Anesthesia Systems, Part # 1011-9050-000.

FDA Recall
Open, Classified ·GE Healthcare, LLC·Product code BSZ·May 27, 2022

Auxiliary Common Gas Outlet (ACGO) conversion/install kits sold under product names CONV KIT SCGO TO ACGO and ACGO ASSY FIELD INSTL. These kits are not affected specifically, however are included due to being purchased with or later used to convert to ACGO.

FDA Recall
Open, Classified ·Datex-Ohmeda, Inc.·Product code BSZ·July 12, 2024