XiO RPT System The XiO RTP System is used to create treatment plans for any cancer patient for whom external beam radiat
FDA device recall Z-1197-2014 · posted 2014-03-13 · Terminated
Recall details
- Recalling firm
- Elekta, Inc.
- Reason for recall
- Dose and Monitor Unit values are not computed correctly when Elekta Motorized Wedges are used with Dynamic Conformal arcs.
- Action taken
- Elekta, Inc. issued an Important Safety Notice (LINXi000019) issued February 14, 29, 2014. The Safety Notice identified the product, the problem, and the action to be taken by the customer. All affected customers of the issue globally by February 28, 2014. Provide a fix to the defect in an expeditious timeframe. It is mandatory for all customers to apply the fix. Version 5.00.01 will be released for the fix in March 2014. Follow up with the affected customers for confirmation receipt of the LIN, and confirmation of installation of patch for the fix by November 30, 2014. For questions regarding this recall call 770-670-2422.
- Root cause
- Software design
- Status
- Terminated
- Product code
- MUJ
- Quantity affected
- 1776
- Distribution
- USA including AL, AK, AZ, CA, CO, CT, DE, DC, FL, GA, IL, IN, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NJ, NY, NC, ND, OH, OK, PA, RI, SC, TN, TX, VA, WA, WV, WI, WY, Puerto Rico and Intern
- Date initiated
- 2014-02-17
- Date posted
- 2014-03-13
- Date terminated
- 2015-07-21
- 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 |
|---|---|---|
| XIO RTP SYSTEM (K102216) | Computerized Medical Systems, Inc. | 2010-10-01 |