Focal Radiation Treatment Planning System, Focal Release 4.3.0 through 4.34.01 For use in radiation treatment planning u
FDA device recall Z-2596-2011 · posted 2011-06-20 · Terminated
Recall details
- Recalling firm
- Computerized Medical Systems Inc
- Reason for recall
- Focal: when a plan is sent to Focal from XiO and the structure properties are edited in Focal CT Sim activity, these changes result in changes to the MLC or field size for the plan when they should not. XiO will recalculate dose when modified plan is returned to XiO however the user may not notice that it has changed form the plant they had approved earlier. Editing the structure properties (col
- Action taken
- Computerized Medical Systems Inc sent a Customer Advisory, dated 11/30/07, was sent to consignees December 2007 to notify them of the issue and how to avoid the workaround. The advisory listed the problem, clinical impact, and a workaround. The firm will be sending each site a reminder that the issues is resolved.
- Root cause
- Software design
- Status
- Terminated
- Product code
- MUJ
- Quantity affected
- 233
- Distribution
- Worldwide Distribution - USA (Nationwide AL, AR, CA, DE, FL, GA, IL, IN, MA, MD, MI, MOP, NE, NY, OH, PA, RI, TX, VA, WA, WI, and WV and the countries of Albania, Argentina, Belgium, Bosnia and Herzeg
- Date initiated
- 2007-11-30
- Date posted
- 2011-06-20
- Date terminated
- 2014-04-10
- Location
- Maryland Heights, MO
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| FOCAL SIM (K013112) | Computerized Medical Systems, Inc. | 2001-12-05 |