Focal Sim radiation therapy treatment planning system
FDA device recall Z-1244-2015 · posted 2015-03-04 · Terminated
Recall details
- Recalling firm
- Elekta, Inc.
- Reason for recall
- Incorrect CT to ED when using the Monaco Image Statistics Tool.
- Action taken
- An Important User Notice (IUN 382-03-FCL-001) was issued to customers on 12/19/2014. The notice included a workaround to be used until a new software release. The notice also included an acknowledgement form to be returned.
- Root cause
- Software design
- Status
- Terminated
- Product code
- MUJ
- Quantity affected
- 907
- Distribution
- Worldwide distribution. US nationwide (AL, AK, CA, CO, CT, FL, IL, IN, LA, MD, MA, MI, MO, MT, NJ, NY, NC, OH, OK, OR, PA, SC, TN, TX, VA, WA, WY, DC), Puerto Rico, Argentina, Austria, Australia, Bulg
- Date initiated
- 2014-12-19
- Date posted
- 2015-03-04
- Date terminated
- 2017-08-07
- Location
- Atlanta, GA
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 |