XiO Radiation Treatment Planning System, XiO Release 4.3.1 through 4.40.00. Used to create treatment plans for any cance
FDA device recall Z-2567-2011 · posted 2011-06-15 · Terminated
Recall details
- Recalling firm
- Computerized Medical Systems Inc
- Reason for recall
- XiO Software: Under certain conditions, when the port shape is altered, dose is not recalculated. The port-change flag is not being set correctly when the port shape is regenerated. The dose distribution will not match the blocking displayed and the mis-match might not be obvious. Monitor Unit calculations will also be based on an incorrect dose distribution. This problem has existed since Re
- Action taken
- Computerized Medical Systems, Inc. sent a "XiO CUSTOMER ADVISORY" letter dated December 8, 2008 to all affected customers. The advisory describes the product, problem, and the actions to be taken. The customers were instructed to set the prompt to "Yes" to avoid the problem from occurring according to written instructions provided in the advisory. This problem has existed since Release 4.3.1 and is expected to be resolved with XiO Release 4.50.00. Questions should be directed to the manufacturer's representative at 408-830-8023.
- Root cause
- Software design
- Status
- Terminated
- Product code
- MUJ
- Quantity affected
- 784
- Distribution
- Worldwide Distribution-- USA (nationwide) including Puerto Rico and countries of Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bahamas, Belgium, Bolivia, Bosnia and Herzegovina, Brazil,
- Date initiated
- 2008-12-09
- Date posted
- 2011-06-15
- Date terminated
- 2014-04-09
- Location
- Maryland Heights, MO
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| XIO RTP SYSTEM (K092132) | Computerized Medical Systems, Inc. | 2009-09-24 |