Recall Z-2378-2012 ยท MUJ System, Planning, Radiation Therapy Treatment
RAYSEARCH LABORATORIES AB
The product affected by this notice is sold under the trade name TomoTherapy SharePlan 1.1. To determine if the version you are using is affected, bring up the About box in the SharePlan application and check if the build number reported there is 1.3.1.10. Intended use: t-RayAutoplan is a software that, based on the planned dose distribution from a TomoPlan treatment planning system, generates a
| Date | Sep 14, 2012 (initiated May 30, 2011) |
| Status | Terminated |
| Reason | This field notice concerns two behaviors of the SharePlan (Multiple Fraction Groups and Depth Offset) that may be unexpected and are not clearly described in the user manual. None of these behaviors have 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 delivere |
| Root cause | Labeling False and Misleading |
| Action | RaySearch Laboratories sent an Urgent Field Safety Notice Medical Device Correction dated May 30, 2011, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Consigness were instructed to completely avoid affecting the erroneous behaviour, verify in TomoTherapy Hi-Art that the plans sent to TomoTherapy SharePlan 1.1 only have one single fraction group with a single fraction size,used for all fractions, and do not attempt to import treatment plans having more than one fraction size into the product. To completed avoid affect |
| Quantity | 15 units |
| Distribution | Worldwide Distribution - USA including CA, KY, MI, NY, OK, and OR. Internationally to Canada, Belgium, United Kingdom, Australia, France, Germany, and Poland. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K083264 | RAYAUTOPLAN 1.0 Raysearch Laboratories AB, Jan 22, 2009 |