Focal Radiation Treatment Planning System, Focal Release 4.50.00 and above for use in radiation treatment planning using
FDA device recall Z-2592-2011 · posted 2011-06-20 · Terminated
Recall details
- Recalling firm
- Computerized Medical Systems Inc
- Reason for recall
- Focal: for XiO plans calculated in relative dose mode, the Focal Plan Review application will display the DVH and maximum dose correctly. However, the isodose display is not scaled correctly. If the user evaluated the plan based only on the isodose display, they might misinterpret the actual dose delivered to the patient.
- Action taken
- Elekta / Computerized Medical Systems Inc sent an undated Safety Notice to consignees beginning on May 21, 2010. The notice identified the product, the problem, and a workaround.
- Root cause
- Software design
- Status
- Terminated
- Product code
- MUJ
- Quantity affected
- 308
- Distribution
- Worldwide Distribution - USA (Nationwide including Puerto Rico) Foreign distribution was made to Albania, Australia, Austria, Belgium, Canada, Chile, China, Cyprus, Denmark, Egypt, Estonia, Finland, F
- Date initiated
- 2010-05-10
- Date posted
- 2011-06-20
- Date terminated
- 2014-04-02
- 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 |