Ray Station Radiation Therapy Treatment Planning System, Model Numbers 3.0, 3.5 and 4.0
FDA device recall Z-0281-2014 · posted 2013-11-14 · Terminated
Recall details
- Recalling firm
- RAYSEARCH LABORATORIES AB
- Reason for recall
- Ray Search Laboratories found an issue with the dose calculation for Elekta motorized wedges in Ray Station 3.0, 3.5 and 4.0. The error presents when a wedge is used for a beam and the wedge angle differs from 60 degrees.
- Action taken
- Medical Device Correction Letters dated 10/23/13 were e-mailed to the user accounts on 10/23/13.
- Root cause
- Software design
- Status
- Terminated
- Product code
- MUJ
- Quantity affected
- 195 units domestically
- Distribution
- US Distribution in the states of: California, Colorado, Delaware, Florida, Maryland, Missouri, New Jersey, New York, Ohio, Pennsylvania, Tennessee, and Virginia.
- Date initiated
- 2013-10-23
- Date posted
- 2013-11-14
- Date terminated
- 2017-02-17
- 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 |
| RAYSTATION (K120387) | Raysearch Laboratories AB | 2012-04-06 |