Device product
Multileaf Collimator To be used for single or multiple fractions, delivered as static and/or dynamic beams of radiation, in all areas of the body where such treatment is indicated.
Z-2340-2012
Product summary
- Firm
- Elekta, Inc.
- Event
- Event 62915
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2
- Official record key
device-enforcement:Z-2340-2012
Official wording
Reason: Information released with the product Agility did not originally contain information on compatibility with the add-on Dynamic Multileaf Collimator Apex.
Code information: 152599 and 152678
Distribution pattern: Nationwide Distribution including DC & MD
Derived failure modes
-
Unknown
Information released with the product Agility did not originally contain information on compatibility with the add-on Dynamic Multileaf Collimator Apex.