Recall Z-2340-2012— Elekta, Inc.
Class II · Terminated
Class II FDA medical device recall by Elekta, Inc., initiated 2012-07-27, terminated 2014-10-06. It names one FDA 510(k) clearance: K121328. 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.. Reason: Information released with the product Agility did not originally contain information on compatibility with the add-on Dynamic Multileaf Collimator Apex..
- Recalling firm
- Elekta, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-07-27
- Terminated
- 2014-10-06
- Firm location
- Norcross, GA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Reason for recall
Information released with the product Agility did not originally contain information on compatibility with the add-on Dynamic Multileaf Collimator Apex.
Data sourced from openFDA. This site is unofficial and independent of the FDA.