XiO RTP System The XiO RTP System is used to create treatment plans for any cancer patient for whom external beam radiat
FDA device recall Z-0780-2014 · posted 2014-01-17 · Terminated
Recall details
- Recalling firm
- Elekta, Inc.
- Reason for recall
- When the number of fractions is changed for a proton spot beam, the MU are recomputed and rounded if necessary, but the dose is not recalculated as it should be even after saving and re-opening the plan.
- Action taken
- An Important Safety Notice, LINXIO0017 Proton Sport Beams, Changes in Fractionation not Updating Dose, is in the process of being distributed to affected customers. The release date for this notice is November 25, 2013. The notice included a Confirmation of Receipt which was to be returned to Elekta. For further questions please call (404) 993-5886.
- Root cause
- Software Design Change
- Status
- Terminated
- Product code
- MUJ
- Quantity affected
- 13
- Distribution
- Worldwide Distribution - US Distribution including the states of IL, IN, LA, NJ, TX, WA and WI., and the countries of Belgium, Germany, Italy and Netherlands.
- Date initiated
- 2013-11-25
- Date posted
- 2014-01-17
- Date terminated
- 2014-05-13
- 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 |