32 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Juno DRF System. Mobile X-ray system These are general, multi-function x-ray systems capable of routine radiographs and general fluoroscopy procedures
FDA Recall
Terminated
·Villa Radiology Systems LLC·Product code KXJ·August 2, 2013
Sunisa Flexi-DT Table, Model Numbers: 51335678, 2269647, 2242088-2, 5141609-2, 5115763, and 5128145, Manufactured by Suinsa C Primavera, 39 Pol. Ind. Las Monjas, Tarrejon de Ardaz Madrid 28850 Spain
FDA Recall
Terminated
·GE Healthcare·Product code KXJ·August 1, 2007
Maquet Magnus Carbon-fibre table top; Device Part Number 1180.16xx (x represents a digit from 0-5 and F-for the US market) The carbon-fibre MAGNUS table top serves to support and position patients for surgical procedures and interventional examination immediately before, during and after the surgical phase. The table top is radio translucent and enables intra-operative use of x-ray equipment.
FDA Recall
Terminated
·Maquet Inc.·Product code KXJ·April 15, 2011
Operating room table - Product Usage: intended for use during diagnostic examinations, radiologic procedures or surgical procedures to support and position a patient.
FDA Recall
Terminated
·Deerfield Imaging, Inc.·Product code KXJ·August 25, 2021
Apollo; Models: 9784000131 9784000231 9784020131 9784020231 9784100231 9784120131 9784120231 9784130131 Product Usage: General, multi-function x-ray systems capable of routine radiographs and general fluoroscopy procedures.
FDA Recall
Terminated
·Villa Sistemi Medicali S.P.A. Via delle Azalee·Product code KXJ·December 27, 2016
Apollo EZ; Model: 9784152036 Product Usage: General, multi-function x-ray systems capable of routine radiographs and general fluoroscopy procedures
FDA Recall
Terminated
·Villa Sistemi Medicali S.P.A. Via delle Azalee·Product code KXJ·December 27, 2016
Prestilix 1600X Prestilix system is a fully integrated remote controlled digital radiology system. It is designed for all general radiology applications with or without contract injection and interventional procedures.
FDA Recall
Terminated
·GE Healthcare, LLC·Product code KXJ·March 29, 2019
Operating room table - Product Usage: intended for use during diagnostic examinations, radiologic procedures or surgical procedures to support and position a patient.
FDA Recall
Terminated
·Deerfield Imaging, Inc.·Product code KXJ·August 25, 2021
Juno DFR X-ray system
FDA Recall
Terminated
·Villa Radiology Systems LLC·Product code KXJ·December 14, 2014
Operating room table - Product Usage: intended for use during diagnostic examinations, radiologic procedures or surgical procedures to support and position a patient.
FDA Recall
Terminated
·Deerfield Imaging, Inc.·Product code KXJ·August 25, 2021
Juno DRF; Model: 709020 Product Usage: General, multi-function x-ray systems capable of routine radiographs and general fluoroscopy procedures
FDA Recall
Terminated
·Villa Sistemi Medicali S.P.A. Via delle Azalee·Product code KXJ·December 27, 2016
IMRIS ORT100 Table, Part Number 110470-000
FDA Recall
Terminated
·Deerfield Imaging, Inc.·Product code KXJ·February 20, 2018
Apollo DRF; Model: 9784220831 Product Usage: General, multi-function x-ray systems capable of routine radiographs and general fluoroscopy procedures
FDA Recall
Terminated
·Villa Sistemi Medicali S.P.A. Via delle Azalee·Product code KXJ·December 27, 2016
Karl Storz SE & Co. KG, C-MAC Video Laryngoscope MIL # 1, for the following REF numbers: 1. 8403xx series, which includes: 8403AX, AXC, BX, BXC, DXC, EXC, GXC, HX, HXK, HXP, KXC, MXC 2. 8401xx series, which includes: 8401AX, AXC, BX, BXC, DXC, GXC, HX, HXP, KXC. Product Usage: Video Laryngoscopes are used to visualize the airways and vocal cords during endotracheal intubation and for the inspection and examination of the upper respiratory tract. Video Laryngoscopes are designed for transient use in invasive procedures through a body orifice.
FDA Recall
Terminated
·Karl Storz Endoscopy·Product code EQN·December 6, 2019
X-Ray High Voltage Generator, Model KXO-80G used on Image Intensified Fluoroscopoc X-Ray System DUA-450D
FDA Recall
Terminated
·Toshiba American Med Sys Inc·Product code rad·September 7, 2004
IntelliVue Clinical Information Portfolio (ICIP) Critical Care Release D, Version D.02. Intended for use in data collection, storage, and management with independent bedside devices, and ancillary systems that are connected either directly or through networks. It is indicated for use by healthcare providers whenever there is a need for generation of a patient record and computation of drug dosage.
FDA Recall
Terminated
·Philips Healthcare Inc.·Product code DXJ·October 21, 2009
Spacelabs Model 91367 SL 2200 Compact Monitor Spacelabs Medical patient monitors passively display data generated from Spacelabs Medical patient parameter modules, Flexport interfaces, gas analyzers, and other SDLC based products.
FDA Recall
Terminated
·Spacelabs Healthcare, Incorporated·Product code DXJ·November 6, 2009
Spacelabs Medical Flat Panel Display is a touchscreen display, 19-inch thin film transistor liquid crystal display (TFT-LCD). The PNs are 010-1619-00 and 010-1655-00, Models 94260-19 and 94256.
FDA Recall
Terminated
·Spacelabs Healthcare, Llc·Product code DXJ·March 20, 2009
Neoligaments Staple Impactor, 6 mm Staple Impactor: 202-3001
FDA Recall
Terminated
·Xiros Plc 28-30 Blenheim Terrace Leeds United Kingdom·Product code HXJ·May 17, 2006
IntelliVue Clinical Information Portfolio Critical Care Release D, Version D.00.00 Product Number: 865047. This device is a clinical information system intended for use in data collection, storage, and management with independent bedside devices, and other systems that are connected either directly or through networks. It is used when there is a need for generating patient records and computation of drug dosage.
FDA Recall
Terminated
·Philips Medical Systems·Product code DXJ·March 4, 2008