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.
This recall has been terminated (originally issued September 10, 2012).
- Company
- Elekta, Inc.
- Recall Initiated
- July 27, 2012
- Posted
- September 10, 2012
- Terminated
- October 6, 2014
- Recall Number
- Z-2340-2012
- Quantity
- 2
- Firm Location
- Norcross, GA
- Official Source
- View on FDA website ↗
Reason for Recall
Information released with the product Agility did not originally contain information on compatibility with the add-on Dynamic Multileaf Collimator Apex.
Distribution
Nationwide Distribution including DC & MD
Lot / Code Info
152599 and 152678
Root Cause
Error in labeling
Action Taken
ELEKTA sent an Important Field Safety Notice, FCO Ref: 20001405000 dated July 7, 2012, to current Agility users and a separate notice FCO Ref: 20001407026 for current Apex users who may be in the process of considering an upgrade to Agility. Both notices made it clear that Apex has not been integrated or classified as compatible for use with Agility. Users are advised not to use Apex with Agility. For questions regarding this recall call 770-300-9725.