Focal Radiation Treatment Planning System, Focal Release 4.40.00 and above. Product Usage: for use in radiation treatmen
FDA device recall Z-2594-2011 · posted 2011-06-20 · Terminated
Recall details
- Recalling firm
- Computerized Medical Systems Inc
- Reason for recall
- Focal: the couch position can be moved between scans of the same CT study. When the images are imported into Focal, the software is not checking the DICOM Image Position (Patient) tag and therefore is not aligning the images sets if there are different couch positions indicated. A shift between image sets will exist of the same amount that the CT couch was moved.
- Action taken
- Elekta CMS Software sent an "ADVISORY NOTICE" dated January 19, 2009 to its affected customers. The notice identified the product, the problem, and the acton to be taken. Customers were informed that the workaround method available is to (use the image fusion feature already in Focal to relign the scans). The firm states that this issue is resolved in Focal version 4.62.00, which was released in March 2011. If you have any questions, please call 314-993-0003 or toll free 800-878-4267.
- Root cause
- Software design
- Status
- Terminated
- Product code
- MUJ
- Quantity affected
- 31
- Distribution
- Worldwide Distribution -- USA (nationwide) including states of: CA, CO, FL, IL, IN, KS, MO, NC, OH, OK, PA, TN, and WA. and countries of Australia, Austria, Canada, India, Netherlands, Portugal, Singa
- Date initiated
- 2009-01-19
- Date posted
- 2011-06-20
- Date terminated
- 2014-04-10
- 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 |