FOCAL Sim Workstation, Radiation Treatment Planning System. Used for patient contouring and viewing of treatment plan ou
FDA device recall Z-2574-2014 · posted 2014-09-03 · Terminated
Recall details
- Recalling firm
- Elekta, Inc.
- Reason for recall
- When DICOM is exporting an arc plan (VMAT, Dynamic Conformal of 3D Static Arcs) and using the Composite Field Sequencing (CFS) feature, the DICOM exported plan will not match the approved treatment plan.
- Action taken
- Elekta, Inc. issued an Urgent Important Field Safety Notice letter (IFSN 382-01-MON-001) to all affected customers.. Confirmation of receipt is to be completed by October 31, 2014. The problem will be resolved in a patch to Focal 4.80. Development is underway with a release date of September 2014 with confirmation of installation of the patch for the fix no later than 6 months from release of the patch. An updated notice from the manufacturer is also being sent to affected customers (FCO: 382-01-MON-001 VID:2.0). For questions contact your local Elekta office.
- Root cause
- Software design
- Status
- Terminated
- Product code
- MUJ
- Quantity affected
- 554 units
- Distribution
- Worldwide Distribution - US (nationwide)in the states of AK, CA, FL, MI, MN, MO, NJ, NY, NC, OH, PA, TN, VA,WA and Puerto Rico, Algeria, Antigua & Barbuda, Australia, Austria, Bahrain, Belarus, Brazil
- Date initiated
- 2014-08-18
- Date posted
- 2014-09-03
- Date terminated
- 2017-08-08
- Location
- Atlanta, GA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| FOCAL SIM (K013112) | Computerized Medical Systems, Inc. | 2001-12-05 |