Z-0169-2013Class II

MOSAIQ MOSAIQ is an image-enabled electronic medical record system (EMR) used for oncology workflow...

Name: Z-0169-2013 MOSAIQ MOSAIQ is an image-enabled electronic medical record system (EMR) used for oncology workflow...
Creator: Elekta, Inc.
Published: 2012-09-18
License: https://open.fda.gov/license/

Elekta Limited / initiated 2012-09-18 / Terminated / root cause: design

FDA source

Elekta, Inc. began a recall of MOSAIQ MOSAIQ is an image-enabled electronic medical record system (EMR) used for oncology workflow management. It lets users supply electronic patient charts... on 2012-09-18. FDA classified it as Class II and gives the reason as "A patient was seriously mistreated after a user made and saved an inadvertent change to the definition of a treatment filed in MOSAIQ". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0169-2013
Classification: Class II
Status: Terminated
Initiated: 2012-09-18
Posted: 2012-10-30
Terminated: 2013-06-06
Recalling firm: Elekta Limited
Product: MOSAIQ MOSAIQ is an image-enabled electronic medical record system (EMR) used for oncology workflow management. It lets users supply electronic patient charts and assemble care plans, order diagnostic tests, and prescribe medications. It also lets users import, view, annotate, manipulate, enhance, manage, and archive images.
Product code: IYE Accelerator, Linear, Medical
Reason for recall: A patient was seriously mistreated after a user made and saved an inadvertent change to the definition of a treatment filed in MOSAIQ.
Root cause tag: design
FDA root cause: Device Design
Action: The firm, MOSAIQ, sent an "IMPORTANT SAFETY NOTICE- LINMSQ0003" was sent to consignees/customers on September 18, 2012. The notice described the product, problem and actions to be taken. The customers were instructed to check their Department Setup configuration settings, and re-enable the Field Edit Delta Display feature if they have disabled it. Note: sites can take this action without an upgrade/patch. The customers were also instructed to complete and return the CONFIRMATION OF RECEIPT form via fax to: 702-992-5002 in US or +44 (0)1293 654401 in OUS, Attn: Elekta OIS Support; scan and email to: [email protected] or [email protected]; Attn: Elekta OIS Support and/or mail to: C/O Elekta OIS Support, 2310 Corporate Circle, Suite 275, Henderson, NV, USA; or C/O Elekta OIS Support, Elekta Limited, Linac House, Fleming Way, Crawley, West Sussex, RH10 9RR, UK. (Note: Product upgrade/patch is not mandatory or even necessary to reduce the related risk.) For questions, concerns, and requests for upgrade, email: [email protected] (North America and Rest of World) or [email protected] (Europe) or call Vice President of RA/QA RNA at 770-670-2548.
Quantity in commerce: 300
Distribution: Worldwide distribution: USA (nationwide) and country of Canada.
Product codes and lots: Version 2.00 to 2.41

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0169-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0169-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-07	2012-10-30

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)