VariSource iX, Software Version 1.1, Part Number AL20020000 VariSource iX Afterloader. The VariSource iX Series High Dos
FDA device recall Z-0325-2012 · posted 2011-12-01 · Terminated
Recall details
- Recalling firm
- Varian Medical Systems, Inc.
- Reason for recall
- VariSource iX console software may cause incorrect dwell times to be delivered to patient and may result in a mistreatment.
- 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.
- Root cause
- Software design
- Status
- Terminated
- Product code
- JAQ
- Quantity affected
- 72 worldwide/50 in U.S.
- Distribution
- Worldwide Distribution-USA (nationwide)
- Date initiated
- 2010-03-01
- Date posted
- 2011-12-01
- Date terminated
- 2013-05-30
- Location
- Charlottesville, VA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VARISOURCE IX HDR AFTERLOADER (K071467) | Varian Medical Systems, Inc. | 2007-07-16 |