MOSAIQ Product Usage: MOSAIQ is an oncology information system used to manage workflows for treatment planing and delive
FDA device recall Z-0221-2015 · posted 2014-11-15 · Terminated
Recall details
- Recalling firm
- Elekta, Inc.
- Reason for recall
- A problem can exist in MOSAIQ resulting in the display of incorrect numeric data due to a dose rounding error on printed reports.
- Action taken
- Elekta sent an Urgent Important Field Safety Notice letter to alert customers of the issue. This notice was distributed on November 3, 2014. A fix to the defect has been developed and has been released by Product Creation. For question call 408-830-8000.
- Root cause
- Software design
- Status
- Terminated
- Product code
- IYE
- Quantity affected
- 15
- Distribution
- US Nationwide Distribution in the states of AZ. CO, IL, MD, MO, NY, OK, OR, PA, RI, TX, VA
- Date initiated
- 2014-11-03
- Date posted
- 2014-11-15
- Date terminated
- 2015-07-27
- 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 |