RecallRadar

FDA Device recall Z-0885-2013

Elekta, Apex add-on Micro MLC, collimator for radiation therapy

On 2013-03-06 the FDA classified a Class II recall of Elekta, Apex add-on Micro MLC, collimator for radiation therapy by Elekta, citing if the Apex collimator is incorrectly installed on the radiation head, a touchguard inhibit activates the view restrictions dialog box only shows the top 12 restrictions.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0885-2013
ClassificationClass II
Statusterminated
Initiated2013-01-18
Published2013-03-06
Last updated2026-09-13 11:53 UTC
CompanyElekta
DistributionUS

Product

Elekta, Apex add-on Micro MLC, collimator for radiation therapy.

Reason

If the Apex collimator is incorrectly installed on the radiation head, a touchguard inhibit activates the view restrictions dialog box only shows the top 12 restrictions.

Identifiers

code_info152652

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-0885-2013%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.