Recall Z-1807-2014 ยท IYE Accelerator, Linear, Medical
Elekta, Inc.
iGUIDE System Product Usage: The intended use of the device is the control of accurate patient positioning with the assistance of a 30 Tracking System in a radiotherapy environment.
| Date | Jun 17, 2014 (initiated May 29, 2014) |
| Status | Terminated |
| Reason | A bug in the software prevents the iGUIDE software from logging off. |
| Root cause | Software design |
| Action | Elekta sent an Important Field Safety Notice 618 01 303 024 dated May 29, 2014 to affected customers. The letter identified the affected product, problem, potential clinical impact and actions to be taken. It also gives a recommendation how the risk can be mitigated - Users should only use the iGUIDE software when the key is in the on position and the Position Guard is active. Users are advised to restart the workstation if any error occurs to ensure the software is running properly. The notice also advises the customer that a patch will be released that corrects the behavior of the iGUIDE |
| Quantity | 224 |
| Distribution | Worldwide Distribution - USA (nationwide) in the states of AZ, CA, CT, HI, IL, IA, KY, MD, MA, MI, MO, NH, NJ, NC, ND, OH, OK, OR, PA, TX, VA, WA, WI, and the countries of Algeria, Australia, Austria, Brazil, Canada, China, Colombia, Denmark, Finland, France, Germany, Hong Kong, India, Italy, Japan, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K072079 | IGUIDE SYSTEM Medical Intelligence Medizintechnik-GmbH-An Elekta, Aug 14, 2007 |