Recalls / —
—#112031
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.
- FDA product code
- IYE — Accelerator, Linear, Medical
- Device class
- Class 2
- Medical specialty
- Radiology
- 510(k) numbers
- K121328
- Affected lot / code info
- 152599 and 152678
Why it was recalled
Information released with the product Agility did not originally contain information on compatibility with the add-on Dynamic Multileaf Collimator Apex.
Root cause (FDA determination)
Error in labeling
Action the firm took
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.
Recalling firm
- Firm
- Elekta, Inc.
- Address
- 4775 Peachtree Industrial Blvd, Bldg 300 # 300, Norcross, Georgia 30092-3011
Distribution
- Distribution pattern
- Nationwide Distribution including DC & MD
Timeline
- Recall initiated
- 2012-07-27
- Posted by FDA
- 2012-09-10
- Terminated
- 2014-10-06
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #112031. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.