Z-1944-2012Class II

MOSAIQ Oncology Information Systems interfaced to Elekta Treatment machines. An image enabled electronic...

Name: Z-1944-2012 MOSAIQ Oncology Information Systems interfaced to Elekta Treatment machines. An image enabled electronic...
Creator: Impac Medical Systems Inc
Published: 2012-06-08
License: https://open.fda.gov/license/

Elekta Limited / initiated 2012-06-08 / Terminated / root cause: software

FDA source

Impac Medical Systems Inc began a recall of MOSAIQ Oncology Information Systems interfaced to Elekta Treatment machines. An image enabled electronic medical record system used for oncology workflow... on 2012-06-08. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1944-2012
Classification: Class II
Status: Terminated
Initiated: 2012-06-08
Posted: 2012-07-06
Terminated: 2013-06-19
Recalling firm: Elekta Limited
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
Product code: IYE Accelerator, Linear, Medical
Reason for recall: 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.
Root cause tag: software
FDA root cause: Software design
Action: A User Notice began being distributed on June 8, 2012. This will be followed by contact at each site by IMPAC support to determine if the site is affected by this issue, and if so, the upgraded version will be suggested. The Notice identified the affected device, the problem, the clinical impact, along with the interim mitigations and the final resolution. Users are encouraged to monitor daily delivery and recordings of treatments to be sure that the Wedge Motor Units treatments are properly delivered. The letter also recommends that treatment charts be checked weekly and that users not override any parameters in MOSAIQ until the machine setup has been completed. Users are to contact Elekta Support for the upgrade.
Quantity in commerce: 11 affected sites
Distribution: Worldwide Distribution -- USA, including the states of VA, CT, GA, NJ and NY and the countries of Belgium, Denmark, France, and the United Kingdom.
Product codes and lots: Version 2.10 - all builds and version 2.20 - builds up to and including 2.20.07A7.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1944-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1944-2012	Class II	Terminated	Voluntary: Firm initiated	2012-07-18	2012-07-06

Product code IYE

K120067Class IIMosaiq Oncology Information SystemImpac Medical Systems, Inc. / cleared 2012-02-28

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)