XiO Radiation Treatment Planning System, Release 4.51.00.
FDA device recall Z-1209-2010 · posted 2010-03-25 · Terminated
Recall details
- Recalling firm
- Computerized Medical Systems Inc
- Reason for recall
- Inconsistent MLC positions, dose, and monitor units
- Action taken
- Elekta contacted customers by phone and mail beginning February 22, 2010, explaining the affected product and providing software update information. For further information, contact Elekta at 1-408-830-8023.
- Root cause
- Software design
- Status
- Terminated
- Product code
- MUJ
- Quantity affected
- Planning system is loaded 25 in locations
- Distribution
- Worldwide Distribution -- United States (PA, AZ, CA, MN, OH, WI, NC, FL, TX, NY and WI), Australia, The Netherlands and India.
- Date initiated
- 2010-02-22
- Date posted
- 2010-03-25
- Date terminated
- 2011-08-24
- 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 |
|---|---|---|
| XIO RTP SYSTEM (K092132) | Computerized Medical Systems, Inc. | 2009-09-24 |