167 results
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15ms
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Sources: EU EUDAMED, US FDA
Philips Allura Xper FD20 Ceiling version only; 722028; imaging applications.
FDA Recall
Terminated
·Philips Electronics North America Corporation·Product code OWB·November 3, 2015
Allura Xper FD OR Table, Ceiling version only; 722035; imaging applications.
FDA Recall
Terminated
·Philips Electronics North America Corporation·Product code OWB·November 3, 2015
ThermoFlo 1 HME, Disposable, Non-sterile, Expiry date 04/17. Used as a humidifier in a breathing circuit.
FDA Recall
Terminated
·Arc Medical Inc·Product code BYD·February 19, 2015
Varian brand VARiS 1.4g (Medical Charged Particle Radiation Therapy System, Record and Verify System); Linear Accelerator with RTP Exchange v6.2, v6.6, & v8.0, All Models; Varian Medical Systems, Palo Alto, CA
FDA Recall
Terminated
·Varian Medical Systems Inc·Product code IYE·October 2, 2007
Milex Arcing Diaphragm Size 95; Model Number: MXWS95
FDA Recall
Terminated
·CooperSurgical, Inc.·Product code HDW·February 16, 2016
Apex Arc Hip Stem, Size 2, HA Coated; Product Code: HC-21002-HA
FDA Recall
Terminated
·Omnilife Science Inc.·Product code LZO·May 9, 2014
Varian brand Trilogy System with RapidArc, Model Numbers: H14, H26, H27, H29; Distributed and Manufactured by: Varian Medical Systems Inc., Palo Alto, CA
FDA Recall
Terminated
·Varian Medical Systems Inc.·Product code IYE·July 20, 2010
Leksell Vantage Stereotactic System. Instrument Carrier, Part of Leksell Vantage Arc (1053958). Neurological stereotaxic Instrument
FDA Recall
Terminated
·Elekta Inc·Product code HAW·March 30, 2020
OrthoSensor VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Right, REF ZBH-PSNCRCD39-R.
FDA Recall
Terminated
·Orthosensor, Inc.·Product code ONN·July 12, 2018
OrthoSensor VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Left, REF ZBH-PSNCRCD39-L.
FDA Recall
Terminated
·Orthosensor, Inc.·Product code ONN·July 12, 2018
Capintec CRC 25 PET, item number 5130-3217 with Software Revisions 2.01 and 2.02 PET dose calibrator
FDA Recall
Terminated
·Capintec Inc·Product code KPT·July 8, 2011
Stryker Howmedica Osteonics, Super SecurFit HA Hip Stem; Sterile Arc Deposited, V40 taper Not for use with 16mm heads.
FDA Recall
Terminated
·Stryker Howmedica Osteonics Corp.·Product code MEH·January 14, 2009
Trident PSL Acetabular Shell;Arc Deposited;Hydroxylapatite Coated;Cluster Screw Holes;Howmedica Osteonics Corp., 325 Corporate DriveMahway, NJ 07430
FDA Recall
Terminated
·Stryker Howmedica Osteonics Corp.·Product code MEH·March 13, 2006
Varian Multileaf Collimator [MLC]; Millenium Multileaf Collimator [52, 80, 120 leaf]; High Definition 120 Multileaf Collimator Model Number(s): product code: H54 and H56; MLC software version 8.5 - Product Usage: is intended to assist the clinician in the delivery of external beam radiation to defined target volumes during radiosurgery and radiotherapy while sparing surrounding normal tissue and critical organs from excess radiation.
FDA Recall
Terminated
·Varian Medical Systems, Inc.·Product code IYE·August 12, 2019
Stryker Howmedica Osteonics, Primary Super SecurFit Stems, hip prosthesis, Sterile; Arc Deposited, V40 taper Not for use with 16mm heads.
FDA Recall
Terminated
·Stryker Howmedica Osteonics Corp.·Product code MEH·January 14, 2009
VerSys Cemented Revision Calcar (CRC) Hip System Femoral Stems VerSys Heritage Hip System Revision Femoral Stems. Indicated for total hip arthroplasty.
FDA Recall
Terminated
·Zimmer, Inc.·Product code JDI·August 28, 2013
Apex ARC Hip Stem, HA Coated, Size 5; Product Code: HC-21005-HA Product Usage: The Apex ARC Hip Stem is the femoral component of a primary or revision total hip replacement. This femoral hip stem is intended for press-fit application and is provided sterile for single use. They are manufactured from titanium alloy. The stem has a proximal porous coating of titanium plasma spray under a coating of hydroxyapatite (HA)
FDA Recall
Terminated
·Omnilife Science Inc.·Product code LZO·June 3, 2015
Varian brand 4D Integrated Treatment Console (4DITC) Radiation Therapy, Interpretation of a RapidArc Treatment Plan as a 3D Conformal Arc Treatment Plan; version v8.6 or 8.8 in combination with treatment planning systems; Model Number: H51; Reference/PSCA Identifier: CP-03063; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA Product Usage: 4D Integrated treatment console is designed to assist the operator of a radiation device in providing accurate treatment set-ups for each patient by monitoring set up parameters and preventing the radiation therapy device from commencing irradiation while any parameter is out of conformance with the treatment plan.
FDA Recall
Terminated
·Varian Medical Systems, Inc. Oncology Systems·Product code IYE·June 27, 2011
Artiste MV SA Linear Accelerator with syngo RT Therapist Version 4.1 build 67 and build 122. Manufactured by Siemens Medical Solutions Oncology Care Systems, Concord, CA.
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code IYE·October 23, 2008
Trident Hemispherical Multi Arc Deposited; Hydroxylapatite Coated; Multiholed; Use with Size A insert; hip prosthesis component, Stryker Orthopaedics, Howmedica Osteonics Corp, Mahwah, NJ 07430
FDA Recall
Terminated
·Stryker Howmedica Osteonics Corp.·Product code MEH·January 21, 2008