Date Initiated by Firm | December 04, 2018 |
Create Date | December 27, 2018 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-0686-2019 |
Recall Event ID |
81705 |
510(K)Number | K141572 |
Product Classification |
Accelerator, linear, medical - Product Code IYE
|
Product | MOSAIQ Oncology Information System Version 2.64.
MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery |
Code Information |
Software Build(s): 2.64 SP9 and higher; UDI (01)00858164002091(10)2.64.235 |
Recalling Firm/ Manufacturer |
Elekta, Inc. 400 Perimeter Center Ter NE Ste 50 Atlanta GA 30346-1227
|
For Additional Information Contact | Alejandra Carrillo 404-202-4333 |
Manufacturer Reason for Recall | If a Setup field (CT, kV, MV or MVCT) is created by COPYING a treatment field or another setup field, then the
copied field will have the same isocenter as the parent and that isocenter may not be the correct isocenter for
imaging when it is sent to the machine. |
FDA Determined Cause 2 | Software design |
Action | Elekta notified customers on about 12/04/2018 via letter titled, "Urgent Important Field Safety Notification."
The letter contains recommended user action and that appropriate personnel working with the device should be advised on the content of the letter and the letter should be placed in an area accessible to all users. The letter stated that the issue will be resolved in Service Packs to MOSAIQ Releases 2.64, 2.65 and 2.70. Customers will be informed when the fix is available through a Product Bulletin.
An acknowledgement Form was sent as part of the letter to be completed and returned no later than 30 days. The firm can be contacted at 408-830-8000 or 855-693-5358. |
Quantity in Commerce | 551 units |
Distribution | Distributed in the United States and outside of the Unites States: Algeria; Antigua and Barbuda; Argentina; Australia; Belgium; Botswana; Brazil; Canada; China; Colombia; Denmark; France; Germany; India; Indonesia; Iran; Ireland; Israel; Italy; Japan; Latvia; Lebanon; Malaysia; Mexico; Morocco; Myanmar; Netherlands; New Zealand; Norway; Peru; Philippines; Poland; Portugal; Russian Federation; Rwanda; Saudi Arabia; Senegal; Singapore; Slovenia; South Africa; Spain; Sweden; Switzerland; Taiwan; Thailand; Turkey; United Kingdom; Viet Nam |
Total Product Life Cycle | TPLC Device Report |
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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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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510(K) Database | 510(K)s with Product Code = IYE
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