Recall Z-2230-2019 ยท IYE Accelerator, Linear, Medical
Elekta, Inc.
iGUIDE System with software build iGuide 2.2.0, 2.2.1, and 2.2.2
| Date | Jun 19, 2019 |
| Status | Terminated |
| Reason | Potential for iGUIDE to incorrectly monitor the 3D position. |
| Root cause | Software Design Change |
| Action | Elekta, Inc. notified customers on about 06/19/2019 via URGENT IMPORTANT FIELD SAFETY NOTIFICATION" letter. Customers were instructed to follow the below steps: 1. Log on to iGUIDE and move the 3D position. If the 3D position is equal to the PARK position, the system is not affected. 2. If the 3D position is not equal to the PARK position, log on to iGUIDE with Operator and Administrator rights. (If no user is available, go to the iGUIDE User Manager and add an appropriate user.). 3. Move the HexaPOD to the 3D Position (If 3D position is equal to the DRIVE position, both checkmarks wil |
| Quantity | 374 devices |
| Distribution | Nationwide distribution to AK, AL, CA, CO, CT, FL, GA, ID, IL, IN, KY, LA, MA, MD, MI, MN, MO, MT, NC, ND, NM, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, VT, WA, WI. Worldwide distribution to Algeria, Argentina, Australia, Austria, Belgium, Botswana, Canada, Chile, China, Colombia, Cyprus, Czec |
| 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 |