XiO RTP System. Used to create treatment plans for any cancer patient for whom external beam radiation therapy or brachy
FDA device recall Z-0928-2014 · posted 2014-02-04 · Terminated
Recall details
- Recalling firm
- Elekta, Inc.
- Reason for recall
- When bolus is present, the Effective Depth (with bolus) to the weight point returned on the Source Data Report is incorrect.
- Action taken
- Corrective Action 1 - An important safety notice, LINXIO0018 - Incorrect Effective Depth for Bolused Beams is in the process of being distributed to affected customers. (Release date November 25, 2013). Corrective Action 2 - Develop a fix to the defect in an expeditious timeframe and make available in Patch Release 4.0.03 and Release 5.00.01.
- Root cause
- Software design
- Status
- Terminated
- Product code
- MUJ
- Quantity affected
- 1424
- Distribution
- Worldwide Distribution-USA (nationwide) including DC and Puerto Rico and the states of AL, AK, AZ, CA, CO, CT, DE, FL, GA, IL, IN, KS, KY, LA, ME, MD, MI, MN, MS, MO, MT, NE, NV, NJ, NM, NY, NC, ND, O
- Date initiated
- 2013-11-25
- Date posted
- 2014-02-04
- Date terminated
- 2015-12-02
- 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 |