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U.S. Department of Health and Human Services

Class 2 Device Recall Oncology Information System

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  Class 2 Device Recall Oncology Information System see related information
Date Initiated by Firm September 18, 2012
Date Posted October 30, 2012
Recall Status1 Terminated 3 on June 06, 2013
Recall Number Z-0169-2013
Recall Event ID 63335
510(K)Number K120067  
Product Classification Accelerator, linear, medical - Product Code IYE
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.
Code Information Version 2.00 to 2.41
Recalling Firm/
Manufacturer		 Elekta, Inc.
4775 Peachtree Industrial Blvd
Bldg 300, #300
Norcross GA 30092-3011
For Additional Information Contact Thomas Valentine
770-670-2548
Manufacturer 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.
FDA Determined
Cause 2		 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: 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.
Quantity in Commerce 300
Distribution Worldwide distribution: USA (nationwide) and country of Canada.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = IYE and Original Applicant = IMPAC MEDICAL SYSTEMS, INC.
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