Varian High Energy Clinacs, High Energy Accelerator, Radiation Treatment System, Model Numbers: H14, H27, H29, HCX. Prod
FDA device recall Z-1325-2013 · posted 2013-05-15 · Terminated
Recall details
- Recalling firm
- Varian Medical Systems, Inc. Oncology Systems
- Reason for recall
- Under certain conditions, photon beams in High Energy Clinacs may experience a gradual change in beam symmetry, potentially reaching an asymmetry of up to about 7% before interlock occurs. At maximum asymmetry, this may result in no more than about 3.5% dose deviation from expected at any point in the beam, and may result in minor injury to the patient or slightly decreased local disease control.
- Action taken
- Varian sent a Customer Technical Bulletin to all affected customers. The bulletin identified the affected product, problem and actions to be taken. For questions, issues, or concerns contact Varian at 1-888-827-4265 or go to http://my.varian.com
- Root cause
- Process design
- Status
- Terminated
- Product code
- IYE
- Quantity affected
- 3943 units
- Distribution
- Worldwide distribution - USA (nationwide) including Puerto Rico, and countries of: Algeria, Angola, Australia, Austria, Bahrain, Bangladesh, Belarus, Belguim, Brazil, Bosnia and Hezregovina, Bulgaria,
- Date initiated
- 2011-05-31
- Date posted
- 2013-05-15
- Date terminated
- 2013-05-15
- Location
- Palo Alto, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VARIAN HIGH ENERGY LINEAR ACCELERATOR (K100890) | Varian Medical Systems | 2010-07-13 |