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

FDA device recall Z-0169-2013 · posted 2012-10-30 · Terminated

Recall details

Recalling firm

Elekta, Inc.

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.

Action taken

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: support@impac.com or europe.support@impac.com; 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: support@impac.com (North America and Rest of World) or europe.support@impac.com (Europe) or call Vice President of RA/QA RNA at 770-670-2548.

Root cause

Device Design

Status

Terminated

Product code

IYE

Quantity affected

300

Distribution

Worldwide distribution: USA (nationwide) and country of Canada.

Date initiated

2012-09-18

Date posted

2012-10-30

Date terminated

2013-06-06

Location

Norcross, GA

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