C-Series Clinac, Trilogy and Novalis Tx used for SRS treatments, Model Numbers H14, H18, H27, H29, HCX, manufactured by
FDA device recall Z-0910-2011 · posted 2011-01-18 · Terminated
Recall details
- Recalling firm
- Varian Medical Systems Oncology Systems
- Reason for recall
- Product may deliver radiation treatment to areas larger than intended,to healthy tissue.
- Action taken
- Varian sent an URGENT MEDICAL DEVICE CORRECTION letter dated October 8, 2009, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Varian recommended to consignees that test runs be performed prior to actual patient treatment to ensure that the entire system is behaving as intended and that appropriate quality assurance procedures should be followed prior tothe delivery of any treatment plan involving radiation therapy. Operators should monitor the patient and the treatment console continuously during treatment. For questions call USA and Canada - 1-888-827-4265, Europe +41 41 749 8844.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- IYE
- Quantity affected
- 5208 units
- Distribution
- Worldwide Distribution
- Date initiated
- 2009-10-08
- Date posted
- 2011-01-18
- Date terminated
- 2012-02-24
- Location
- Palo Alto, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TRILOGY RADIOTHERAPY DELIVERY SYSTEM AND TRILOGY TX DELIVERY SYSTEM (K070094) | Varian Medical Systems, Inc. | 2007-02-09 |
| VARIAN C-SERIES CLINACS (CLINAC 2300C/D) (K913119) | Varian Assoc., Inc. | 1991-11-07 |