176 results
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51ms
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Sources: EU EUDAMED, US FDA
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Eclipse Radiation Treatment Planning System, model H48; Varian Medical Systems Inc..
FDA Recall
Terminated
·Varian Medical Systems, Inc. Oncology Systems·Product code MUJ·May 3, 2011
Varian brand GammaMed 12i Accessory: Clamping adapters for bronchial catheters, 1.8mm diameter, GammaMed 12i; Ref: BT-00264, Model 2-H63; Product is distributed by Varian Medical Systems Inc., Palo Alto, CA and Manufactured by Varian Medical Systems Haan GmbH, Bergische Strasse 16, D-42781 Haan, Germany. The Varian Medical System GammaMed Afterloader system is a remotely controlled intelligent robotic device intended to be used to deliver high dose-rate radiation therapy, in close proximity to and from within diseased tissues. Palliative care and treatments with curative intent to both benign and non-benign disease using interstitial, intracavitary, intraluminal, intra and inter-operative brachytherapy or combinations of any these treatment types are possible using this device.
FDA Recall
Terminated
·Varian Medical Systems, Inc. Oncology Systems·Product code JAQ·October 6, 2011
Varian brand GammaMed 12i Accessory: Clamping adapters for bronchial catheters, 1.8mm diameter, GammaMed 12i; Ref: BT-00264, Model 1-H63; Product is distributed by Varian Medical Systems Inc., Palo Alto, CA and Manufactured by Varian Medical Systems Haan GmbH, Bergische Strasse 16, D-42781 Haan, Germany. The Varian Medical System GammaMed Afterloader system is a remotely controlled intelligent robotic device intended to be used to deliver high dose-rate radiation therapy, in close proximity to and from within diseased tissues. Palliative care and treatments with curative intent to both benign and non-benign disease using interstitial, intracavitary, intraluminal, intra and inter-operative brachytherapy or combinations of any these treatment types are possible using this device.
FDA Recall
Terminated
·Varian Medical Systems, Inc. Oncology Systems·Product code JAQ·October 6, 2011
GammaMed Plastic Needle with Mandrin; 2.0 mm diameter, length 320 mm. Remote controlled radionuclide applicator system. Varian Medical Systems, Inc. Mfg by Varian Medical Systems Haan GmbH, Haan, Germany. The interstitial plastic needles with 2 mm diameter are designed for interstitial treatments in areas such as head and neck, gynecology, breast or prostate. In order to avoid bending and to facilitate the introduction of the needles, each needle is supplied with a mandrin.
FDA Recall
Terminated
·Varian Medical Systems, Inc.·Product code JAQ·September 30, 2008
GammaMed Plastic Needle with Mandrin; 2.0 mm diameter, length 113 mm. Remote controlled radionuclide applicator system. Varian Medical Systems, Inc. Mfg by Varian Medical Systems Haan GmbH, Haan, Germany. The interstitial plastic needles with 2 mm diameter are designed for interstitial treatments in areas such as head and neck, gynecology, breast or prostate. In order to avoid bending and to facilitate the introduction of the needles, each needle is supplied with a mandrin.
FDA Recall
Terminated
·Varian Medical Systems, Inc.·Product code JAQ·September 30, 2008
GammaMed Plastic Needle with Mandrin; 2.0 mm diameter, length 200 mm. Remote controlled radionuclide applicator system. Varian Medical Systems, Inc. Mfg by Varian Medical Systems Haan GmbH, Haan, Germany. The interstitial plastic needles with 2 mm diameter are designed for interstitial treatments in areas such as head and neck, gynecology, breast or prostate. In order to avoid bending and to facilitate the introduction of the needles, each needle is supplied with a mandrin.
FDA Recall
Terminated
·Varian Medical Systems, Inc.·Product code JAQ·September 30, 2008
Varian Medical Systems FastPlan, versions 5.5 and 5.5.1, model number HZ3, manufactured by Varian Medical Systems, Palo Alto, CA The product is a radiation treatment planning system.
FDA Recall
Terminated
·Varian Medical Systems Oncology Systems·Product code IYE·May 29, 2008
Titanium Fletcher-style Applicator Set - Defined Geometry - CT Compatible with Titanium intrauterine probe with stopper length 40 mm, 30 degree angle. Varian Medical Systems, Palo Alto, CA; Manufactured by Varian Medical Systems Haan GmbH, Haan, Germany. To treat cancer of the uterus, cervix, endometrium and vagina.
FDA Recall
Terminated
·Varian Medical Systems, Inc. Oncology Systems·Product code JAQ·July 13, 2011
Titanium Fletcher-style Applicator Set - Defined Geometry - CT Compatible with Titanium intrauterine probe with stopper length 30 mm, 30 degree angle. Varian Medical Systems, Palo Alto, CA; Manufactured by Varian Medical Systems Haan GmbH, Haan, Germany. To treat cancer of the uterus, cervix, endometrium and vagina.
FDA Recall
Terminated
·Varian Medical Systems, Inc. Oncology Systems·Product code JAQ·July 13, 2011
Titanium Fletcher-style Applicator Set - Defined Geometry - CT Compatible with Titanium intrauterine probe with stopper length 70 mm, 30 degree angle. Varian Medical Systems, Palo Alto, CA; Manufactured by Varian Medical Systems Haan GmbH, Haan, Germany. To treat cancer of the uterus, cervix, endometrium and vagina.
FDA Recall
Terminated
·Varian Medical Systems, Inc. Oncology Systems·Product code JAQ·July 13, 2011
Titanium Fletcher-style Applicator Set - Defined Geometry - CT Compatible with Titanium intrauterine probe with stopper length 60 mm, 30 degree angle. Varian Medical Systems, Palo Alto, CA; Manufactured by Varian Medical Systems Haan GmbH, Haan, Germany. To treat cancer of the uterus, cervix, endometrium and vagina.
FDA Recall
Terminated
·Varian Medical Systems, Inc. Oncology Systems·Product code JAQ·July 13, 2011
Titanium Fletcher-style Applicator Set - Defined Geometry - CT Compatible with Titanium intrauterine probe with stopper length 50 mm, 30 degree angle. Varian Medical Systems, Palo Alto, CA; Manufactured by Varian Medical Systems Haan GmbH, Haan, Germany. To treat cancer of the uterus, cervix, endometrium and vagina.
FDA Recall
Terminated
·Varian Medical Systems, Inc. Oncology Systems·Product code JAQ·July 13, 2011
Titanium Fletcher-style Applicator Set - Defined Geometry - CT Compatible with Titanium intrauterine probe with stopper length 80 mm, 30 degree angle. Varian Medical Systems, Palo Alto, CA; Manufactured by Varian Medical Systems Haan GmbH, Haan, Germany. To treat cancer of the uterus, cervix, endometrium and vagina.
FDA Recall
Terminated
·Varian Medical Systems, Inc. Oncology Systems·Product code JAQ·July 13, 2011
Varian Medical Systems, Varis Vision - RT Chart version 7.3.10. For radiation therapy.
FDA Recall
Terminated
·Varian Medical Systems, Inc. Oncology Systems·Product code IYE·February 7, 2011
GammaMed Flexible Applicator Probe, Part GM11002560 - 3.2 mm diameter braced PVDF. Varian Medical Systems, Palo Alto, CA, Mfg. by Varian Medical Systems, Haan GmbH. Designed for brachytherapy intracavity treatments in areas such as cancer of the vagina, vaginal stump or rectum.
FDA Recall
Terminated
·Varian Medical Systems, Inc.·Product code JAQ·August 5, 2008
GammaMed Flexible Applicator probe; 3.2mm diameter, braced PVDF. Varian Medical Systems, Palo Alto, CA. Mfg by Varian Medical Systems, Haan GmbH. Flexible Applicator Robes are designed for brachytherapy intracavitary treatments in areas such as vagina, vagina stump or rectum.
FDA Recall
Terminated
·Varian Medical Systems, Inc. Oncology Systems·Product code JAQ·July 13, 2011
ARIA, versions 8.0 and 8.1; Varian Medical Systems, Palo Alto, CA. Product Usage: Aria Radiation Oncology product is a treatment and image management application. It enables the authorized user to enter, access, modify, store and archive treatment plan and image data from diagnostic studies.
FDA Recall
Terminated
·Varian Medical Systems, Inc. Oncology Systems·Product code IYE·May 17, 2011
BrachyVision software, catalog #AL15521003, CD-ROM (set of four) packaged in plastic sleeve and inserted into Varian Medical Systems Imaging Products Vision binder. Labeled in part ***Varian Medical Systems Inc. Oncology Systems***
FDA Recall
Terminated
·Varian Brachytherary Virginia·Product code LNX·October 31, 2003
Varian brand Varian Eclipse Treatment Planning System for radiotherapy; Model Number: H48; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA The Eclipse Treatment Planning System (Eclipse TPS) is used to plan radiotherapy treatments for patients with malignant or benign diseases. Eclipse TPS is used to plan external beam irradiation with photon, electron and proton beams, as well as for internal irradiation (brachytherapy) treatments. In addition, the Eclipse Proton Eye algorithm is specifically indicated for planning proton treatment of neoplasms of the eye.
FDA Recall
Terminated
·Varian Medical Systems, Inc. Oncology Systems·Product code MUJ·June 18, 2012
Portal Vision, R-Arm with 4D Integrated Treatment Console; Varian Medical Systems. Palo Alto, CA. The Portal Vision device is used for verification of the treatment field and shielding block in relation to anatomical landmarks in radiotherapy treatment. Portal Vision will also allow for verification of the exit dose in radiotherapy treatment.
FDA Recall
Terminated
·Varian Medical Systems, Inc. Oncology Systems·Product code IYE·November 23, 2011