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.
FDA Recall Z-0169-2013 · Posted 2012-10-30
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Recalling FirmElekta, Inc.
Recall StatusTerminated
Product CodeIYE
Date Initiated2012-09-18
Date Terminated2013-06-06
Product Quantity300
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.
Firm 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.
Root Cause
Device Design
Distribution Pattern
Worldwide distribution: USA (nationwide) and country of Canada.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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