RecallRadar

FDA Device recall Z-2340-2012

Multileaf Collimator To be used for single or multiple fractions, delivered as static and/or dynamic beams of radiation, in all areas of th…

On 2012-09-19 the FDA classified a Class II recall of Multileaf Collimator To be used for single or multiple fractions, delivered as static and/or dynamic beams of radiation, in all areas of th… by Elekta, citing information released with the product Agility did not originally contain information on compatibility with the add-on Dynamic Multileaf Collimator Apex.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-2340-2012
ClassificationClass II
Statusterminated
Initiated2012-07-27
Published2012-09-19
Last updated2026-09-13 11:53 UTC
CompanyElekta
DistributionUS

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.

Identifiers

code_info152599 and 152678

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2340-2012%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.