Recall Z-0456-2014 ยท IYE Accelerator, Linear, Medical
Iba Dosimetry Gmbh
iba COMPASS SW Version 3.0, Catalog Number CS10-100 (medical linear accelerator) radiological
| Date | Dec 6, 2013 (initiated Aug 20, 2013) |
| Status | Terminated |
| Reason | The development partner of IBA informed that there is problem in a SW component used in COMPASS when converting Region of Interest (ROI) geometries to dose grid representation. Under certain conditions this problem generates too large ROI voxel volumes causing erroneous dose statistics and DVHs. |
| Root cause | Software design |
| Action | Iba sent an Field Safety Notice on August 20, 2013, by email and letter delivered by UPS, Please distribute this notice to all those who need to be aware within your area of responsibility where the affected software have been installed (e.g. colleagues, satellites). Please maintain awareness of this notice and resulting action until we have provided you with a new software version. We would kindly ask you to acknowledge the receipt of this Field Safety Notice. Please sign and send back the attached Confirmation of Receipt within four weeks after the receipt of this Field Safety Notice. W |
| Quantity | 33 units |
| Distribution | Worldwide Distribution - US Distribution including the states of CT, MA, OH, CA, SC, NY and OK, and the countries of International distribution (from Germany) Poland, Germany, GB, The Netherlands, Spain, Turkey, Canada, Mexico, China, Hong Kong and Singapore. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K072374 | COMPASS Scanditronix Wellhofer GmbH, Dec 7, 2007 |