Recall Z-1308-2014 ยท MUJ System, Planning, Radiation Therapy Treatment
RAYSEARCH LABORATORIES AB
RaySearch Ray Station, Radiation Therapy Treatment Planning System, Stand-alone software
| Date | Mar 31, 2014 (initiated Feb 6, 2014) |
| Status | Terminated |
| Reason | RaySearch Laboratories has recalled RaySearch Ray Station 4.0 software due to clinical dose calculation errors during radiation therapy. |
| Root cause | Software Design Change |
| Action | On February 6, 2014, RaySearch Laboratories distributed Urgent Medical Device Correction notices to their customers via email regarding the affected product. To determine if the version you are using is affected, bring up the About box in the RayStation application and check if the number reported is "4.0.2.9". If so, the notice applies to your version. Customers are advised to inform all planning staff and all users about the instructions listed on the notice. Customers are advised to inspect their system and identify all installed units with the referenced software version numbers listed |
| Quantity | 19 units (16 units domestically & 3 units internationally) |
| Distribution | OH, MD, NJ, WA, IL, MA, FL, Spain, United Kingdom, Italy, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K130617 | RAYSTATION Raysearch Laboratories AB, May 10, 2013 |