RecallRadar

FDA Device recall Z-1944-2012

MOSAIQ Oncology Information Systems interfaced to Elekta Treatment machines

On 2012-07-18 the FDA classified a Class II recall of MOSAIQ Oncology Information Systems interfaced to Elekta Treatment machines by Impac Medical Systems, citing impac Medical became aware of a problem with the recording of the Wedge Motor Units in MOSAIQ when it resumes after a machine terminates/faults, the remaining Wedge MU was being e….

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1944-2012
ClassificationClass II
Statusterminated
Initiated2012-06-08
Published2012-07-18
Last updated2026-09-13 11:53 UTC
CompanyImpac Medical Systems
DistributionCT, GA, NJ, NY, VA

Product

MOSAIQ Oncology Information Systems interfaced to Elekta Treatment machines. An image enabled electronic medical record system used for oncology workflow management. Manufactured by: Impac Medical Systems 100 Mathilda Place, 5th floor Sunnyvale, Ca 94086

Reason

Impac Medical became aware of a problem with the recording of the Wedge Motor Units in MOSAIQ when it resumes after a machine terminates/faults, the remaining Wedge MU was being erroneously set to zero.

Identifiers

code_infoVersion 2.10 - all builds and version 2.20 - builds up to and including 2.20.07A7.

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-1944-2012%22

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