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.
This recall has been terminated (originally issued December 1, 2011).
- Company
- Varian Medical Systems, Inc.
- Recall Initiated
- March 1, 2010
- Posted
- December 1, 2011
- Terminated
- May 30, 2013
- Recall Number
- Z-0325-2012
- Quantity
- 72 worldwide/50 in U.S.
- Firm Location
- Charlottesville, VA
- Official Source
- View on FDA website ↗
Reason for Recall
VariSource iX console software may cause incorrect dwell times to be delivered to patient and may result in a mistreatment.
Distribution
Worldwide Distribution-USA (nationwide)
Lot / Code Info
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
Root Cause
Software design
Action Taken
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.