High-Definition 120 Multileaf Collimator HD 120 MLC is an accessory x-ray collimator designed to be mounted on Varian Tr
FDA device recall Z-3052-2011 · posted 2011-08-22 · Terminated
Recall details
- Recalling firm
- Varian Medical Systems, Inc. Oncology Systems
- Reason for recall
- When using the HD120 Multi Leaf Collimator for beam shaping, and under specific treatment conditions, dose may be delivered outside of the intended treatment field that exceeds the expected transmission dose.
- Action taken
- Varian Medical Systems sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated June 6, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. ***12-20-12, AMENDED INFO ***: An additional letter was sent to consignees on 11/5/12 that Varian identified as also being affected by the recall.*** The letter describes various jaw position recommendations to be followed when planning and treating dynamic fields on the HD120 MLC. Contact the Varian Oncology Help Desk at 1-888-827-4265 for questions regarding this notice.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- IYE
- Quantity affected
- 173***12-20-12 AMENDED TO: 106 units***
- Distribution
- Worldwide Distribution.
- Date initiated
- 2011-06-06
- Date posted
- 2011-08-22
- Date terminated
- 2011-12-23
- 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 |