Multileaf Collimator To be used for single or multiple fractions, delivered as static and/or dynamic beams of radiation,
FDA device recall Z-2340-2012 · posted 2012-09-10 · Terminated
Recall details
- Recalling firm
- Elekta, Inc.
- Reason for recall
- Information released with the product Agility did not originally contain information on compatibility with the add-on Dynamic Multileaf Collimator Apex.
- 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.
- Root cause
- Error in labeling
- Status
- Terminated
- Product code
- IYE
- Quantity affected
- 2
- Distribution
- Nationwide Distribution including DC & MD
- Date initiated
- 2012-07-27
- Date posted
- 2012-09-10
- Date terminated
- 2014-10-06
- Location
- Norcross, GA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AGILITY (K121328) | Elekta , Ltd. | 2012-06-12 |