Varian brand Varian 52-leaf Standard MLC multileaf collimator; Reference/FSCA Identifier: CP-04792; Model Number(s): All
FDA device recall Z-1090-2012 · posted 2012-02-23 · Terminated
Recall details
- Recalling firm
- Varian Medical Systems, Inc. Oncology Systems
- Reason for recall
- When using the Standard and Millennium 52-leaf MLC multi-leaf collimators for beam shaping, under specific treatment conditions, dose may be delivered outside of the intended treatment field that exceed the expected transmission dose.
- Action taken
- Varian Medical Systems sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated January 16, 2012 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. The letter provides recommended actions when planning and treating dynamic fields on the 52 leaf MLCs. Contact the Help Desk at 1-888-827-4265 for questions regarding this recall.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- IYE
- Distribution
- Worldwide Distribution-USA (nationwide) including Puerto Rico and the countries of Canada, China, Austria, Belgium, Denmark, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Netherla
- Date initiated
- 2012-01-16
- Date posted
- 2012-02-23
- Date terminated
- 2012-07-26
- 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 |
|---|---|---|
| HIGH-DEFINITION 120 MULTILEAF COLLIMATOR (HD120 MLC) (K071992) | Varian Medical Systems | 2007-08-15 |
| MILLENNIUM MULTI-LEAF COLLIMATOR (K050442) | Varian Medical Systems | 2005-03-23 |
| VARIAN MULTILEAF COLLIMATOR (K943224) | Varian Assoc., Inc. | 1996-02-02 |