Recall Z-2444-2012 ยท MUJ System, Planning, Radiation Therapy Treatment
RAYSEARCH LABORATORIES AB
SharePlan 1.1, aka t-RayAutoplan version 1.2.1 (build number 1.3.1.10). Manufacturing name RayAutoplan, aka t-RayAutoplan, commercial name (TomoTherapy) SharePlan Intended use: t-RayAutoplan is a software that, based on the planned dose distribution from a TomoPlan treatment planning system, generates a family of individually optimized IMRT plans and presents their characteristics to the user in
| Date | Sep 24, 2012 (initiated Oct 10, 2011) |
| Status | Terminated |
| Reason | This notice concerns behavior of the SharePlan that may be unexpected and not clearly described in the user manual. This behavior has not caused patient mistreatment or other incidents. However, the described user actions must be adhered to for best agreement between treatment plan evaluation and the clinical outcome of the delivered treatment. The behavior appears, when importing RFA-files (.asc) |
| Root cause | Labeling mix-ups |
| Action | RaySearch Laboratories sent an Urgent Field Safety Notice Medical Device Correction letter dated October 10, 2011, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the customer. To completely avoid effects of the erroneous behaviour, RFA-file has to be modified to have the crossline profiles sgtored in the X column of the file and the inline profiles in the Y column. Upon request, RaySearch Laboratories will provide help to the customers by transferring the RFA-files to the correct format through a scrip. Customers were instructed to |
| Quantity | 20 units |
| Distribution | Worldwide Distribution - USA including CA, KY, MI, NY, OK, OR, SD, and WI. Internationalyl to Canada, Sweden, France, Germany, Australia, Poland, Belgium, and United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K083264 | RAYAUTOPLAN 1.0 Raysearch Laboratories AB, Jan 22, 2009 |