RecallRadar

FDA Device recall Z-3110-2017

MOSAIQ Medical Charged-Particle Radiation Therapy System

On 2017-09-13 the FDA classified a Class II recall of MOSAIQ Medical Charged-Particle Radiation Therapy System by Elekta, citing the table shift in the vertical direction was inverted during the use of CMA (Couch Move Assistant). Therapy may be directed to an incorrect area.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-3110-2017
ClassificationClass II
Statusterminated
Initiated2017-06-30
Published2017-09-13
Last updated2026-09-13 11:54 UTC
CompanyElekta
DistributionUS

Product

MOSAIQ Medical Charged-Particle Radiation Therapy System

Reason

The table shift in the vertical direction was inverted during the use of CMA (Couch Move Assistant). Therapy may be directed to an incorrect area.

Identifiers

code_infoAll software builds.

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3110-2017%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.