RayStation software version 4.0.3.4 RayStation is a software system designed for treatment planning and analysis of radi
FDA device recall Z-1806-2014 · posted 2014-06-17 · Terminated
Recall details
- Recalling firm
- RAYSEARCH LABORATORIES AB
- Reason for recall
- This notice concerns a problem with the computation of ROI voxel volumes for cases where the CT has variable slice spacing. The dose grid volumetric representation of an ROI can be wrong. This affects all dose-volume properties for such ROIs, including DVH, dose statistics, clinical goals and constraints or objective functions. Furthermore, if material override ROIs are used, or if the external is not represented by contours, the bug can trigger an error in the 3D dose distribution.
- Action taken
- On April 25, 2014, RaySearch emailed all consignees of the affected product a copy of the recall notice as well as the response forms. Back up notification methods include phone calls and site visits.
- Root cause
- Software design
- Status
- Terminated
- Product code
- MUJ
- Quantity affected
- 25 sites/245 units (US), 25 sites/124 units (foreign)
- Distribution
- Worldwide Distribution-USA (nationwide) including the states of AZ, CA, FL, IL, MA, MD, MO, MS, NJ, NV, NY, OH, PA, TN, VA, and WA, and the countries of Australia, Belgium, Germany, France, Italy, New
- Date initiated
- 2014-04-25
- Date posted
- 2014-06-17
- Date terminated
- 2017-06-26
- Location
- Stockholm, Sweden
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| RAYSTATION (K130617) | Raysearch Laboratories AB | 2013-05-10 |