MOSAIQ, an oncology information system used to manage workflows for treatment planning and delivery. It supports informa
FDA device recall Z-1800-2014 · posted 2014-06-16 · Terminated
Recall details
- Recalling firm
- Elekta, Inc.
- Reason for recall
- When using CMA, if the user hovers the mouse pointer exactly above the direction dropdowns and then uses the mouse thumbwheel or touchpad scroll bar, the direction selection might change when the intention was only to move the mouse to a different area of the screen.
- Action taken
- Elekta sent an Important Safety Notice on May 23, 2014, to all affected customers. The notice identified the product the problem and the action needed to be taken by the customer. "Notify the affected customers of the issue - To be completed 06/22/2014 "Provide a fix to the defect in an expeditious timeframe. It is mandatory for all customers to apply the fix - Version 2.50.05 SP8 & Version 2.60 - To be released 05/16/2014 "Follow up with the affected customers for: -Confirmation receipt of the LIN, AND -Confirmation of installation of patch for the fix- To be completed 11/30/2014. For further questions please call (404) 993-5886.
- Root cause
- Software design
- Status
- Terminated
- Product code
- IYE
- Quantity affected
- 723
- Distribution
- Worldwide Distribution - USA (nationwide) including Puerto Rico, and the countries of Albania, Algeria, Argentina, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bosnia and Herzegovina, Br
- Date initiated
- 2014-05-23
- Date posted
- 2014-06-16
- Date terminated
- 2021-07-16
- Location
- Atlanta, GA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MOSAIQ ONCOLOGY INFORMATION SYSTEM (K123230) | Impac Medical Systems, Inc. | 2012-12-12 |