FDA Medical Device Recalls (openFDA)
Varian Medical Systems, Inc.: 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.
- Recall number
- Z-0325-2012
- Recalling firm
- Varian Medical Systems, Inc.
- Product
- 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.
- Status
- Terminated
- Initiated
- 2010-03-01
- Posted
- 2011-12-01
- Terminated
- 2013-05-30
- Reason
- VariSource iX console software may cause incorrect dwell times to be delivered to patient and may result in a mistreatment.
- Root cause
- Software design
- Action
- Varian Medical Systems sent a "MEDICAL DEVICE RECALL" letter dated April 1, 2010 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. Customers were asked to conduct a simple test to establish if their machine is affected by the problem. Device users were requested to complete an attached receipt verification form and return it to Varian BrachyTherapy via fax or e-mail. Call the Contact Service Dispatch number at 1-800-864-1672 for questions regarding this detail.
- Quantity
- 72 worldwide/50 in U.S.
- Distribution
- Worldwide Distribution-USA (nationwide)
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K071467"]
- PMA numbers
- not on file
- Product code
- JAQ
- Firm FEI
- 3000206172
- Firm city
- Charlottesville
- Firm state
- VA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28