Device 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.
Z-0169-2013
Product summary
- Firm
- Elekta, Inc.
- Event
- Event 63335
- Status
- Terminated
- Classification
- Class II
- Quantity
- 300
- Official record key
device-enforcement:Z-0169-2013
Official wording
Reason: A patient was seriously mistreated after a user made and saved an inadvertent change to the definition of a treatment filed in MOSAIQ.
Code information: Version 2.00 to 2.41
Distribution pattern: Worldwide distribution: USA (nationwide) and country of Canada.
Derived failure modes
-
Unknown
A patient was seriously mistreated after a user made and saved an inadvertent change to the definition of a treatment filed in MOSAIQ.