FDA Enforcement
Class II
Terminated
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.
Recall: Z-0169-2013
·
Reported November 7, 2012
Enforcement
- Recall Number
- Z-0169-2013
- Event ID
- 63335
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Elekta, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- November 7, 2012
- Initiation Date
- September 18, 2012
- Classification Date
- October 30, 2012
- Termination Date
- June 6, 2013
- Address
- 4775 Peachtree Industrial Blvd, Bldg 300, #300, Norcross, GA, 30092-3011, United States
Description
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.
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 Info
Version 2.00 to 2.41
Distribution
Worldwide distribution: USA (nationwide) and country of Canada.
Quantity
300