Devices

Device Recall Brachytherapy System, Remote Afterloader

Model / Serial
Serial numbers: 212, 215, 222, 224, 239, 246, 271, 274, 281, 293, 308, 322, 333, 343, 346, 388, 394, 401, 403, 406, 411, 431, 436, 437, 438, 441, 444, 446, 450, 456, 462, 500, 501, 505, 509, 510, 511, 512, 513, 514, 515, 516, 518, 519, 521, 522, 527, 530, 532, 535, 536, 538, 539, 540, 541, 542, 544, 545, 546, 548, 551. Part Number: AL20020000 (VariSource iX Afterloader
Product Classification
Radiology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution-USA (nationwide)
Product Description
VariSource iX, Software Version 1.1, Part Number AL20020000 VariSource iX Afterloader. || The VariSource iX Series High Dose Rate Afterloader system is a computer controlled remote electra/mechanical system used for medical purposes, for placing a NiTiNol wire incorporating an irradiated iridium seed internally or close by, a malignant tumor or tumor bed in a practice known as brachytherapy. The device has up to 20 channels for treatment.
Manufacturer
Varian Medical Systems, Inc.
1 Event
- Recall of Device Recall Brachytherapy System, Remote Afterloader

Manufacturer

Varian Medical Systems, Inc.

Manufacturer Address
Varian Medical Systems, Inc., 700 Harris St Ste 109, Charlottesville VA 22903-4584
Manufacturer Parent Company (2017)
Varian Medical Systems Inc
Source
USFDA

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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