Focal Radiation Treatment Planning Workstation. Focal Release 4.51.00 and above. Allows users to access XiO and other RT
FDA device recall Z-2562-2011 · posted 2011-06-14 · Terminated
Recall details
- Recalling firm
- Computerized Medical Systems Inc
- Reason for recall
- Focal: If a plan involving Dynamic MLC Delivery is sent from XiO to Focal and called up there in Plan Review, the angle of the gantry is set to zero for all beams. If this plan is then sent from Focal to the R&V System, the gantry angles all remain at zero which could lead to patient mistreatment.
- Action taken
- Elekta CMS Software sent a USER NOTICE dated November 5, 2010, to all affected customers. The notice identified the product, the problem, and the action to be taken by the customer. A return postcard was included for the customer to confirm receipt of the User Notice. The firm intends to correct the software so it does not modify anything about the plan sent from XiO. Customers were instructed to contact their local customer support office with any questions.
- Root cause
- Software design
- Status
- Terminated
- Product code
- MUJ
- Quantity affected
- 155
- Distribution
- Worldwide Distribution - USA (nationwide) and the countries of Algeria, Australia, Belarus, Belgium, Brazil, Canada, Chile, China, Egypt, Estonia, Finland, France, Germany, Hong Kong, India, Italy, La
- Date initiated
- 2010-11-09
- Date posted
- 2011-06-14
- Date terminated
- 2014-04-02
- Location
- Maryland Heights, MO
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| FOCAL SIM (K013112) | Computerized Medical Systems, Inc. | 2001-12-05 |