Varian brand TrueBeam and TrueBeam STx, Model Number:TMX- H19, Distributed by and Manufactured by: Varian Medical System
FDA device recall Z-0106-2011 · posted 2010-10-20 · Terminated
Recall details
- Recalling firm
- Varian Medical Systems Oncology Systems
- Reason for recall
- Due to a software anomaly, guidance-based couch shift values may not be applied as expected when the operator selects "Apply Shift" and presses Motion Enable buttons. This can result in the actual patient position differing from that position indicated by the imaging application affecting poistion accuracy and precision.
- Action taken
- Varian Medical Systems issued an Urgent Medical Device Correction letter date dated May 24, 2010 to users identifying the affected device, the issue prompting the correction, and the actions to be taken by the user. Customers were asked to set couch tolerance values to small numbers, and for radiosurgical treatment tolerance values to be set to zero. A Varian representative will contact customers to schedule installation of a software version correcting the issue. US Customers can contact Varian at 1-888-827-4265,. European customers can contact Varian at +41 41 749 8844.
- Root cause
- Software design
- Status
- Terminated
- Product code
- IYE
- Distribution
- Worldwide Distribution: Two consignees, one in the US and one in Switzerland.
- Date initiated
- 2010-05-24
- Date posted
- 2010-10-20
- Date terminated
- 2011-07-20
- Location
- Palo Alto, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TRILOGY MX (K092871) | Varian Medical Systems, Inc. | 2009-11-30 |