Recall Z-3017-2017 ยท IYE Accelerator, Linear, Medical
Elekta, Inc.
iGUIDE Software 2.2 Product Usage: Control of accurate patient positioning with assistance of a 30 Tracking System in a radiotherapy environment.
| Date | Jun 19, 2017 |
| Status | Terminated |
| Reason | Incorrect PEC values. |
| Root cause | Unknown/Undetermined by firm |
| Action | Elekta sent an Urgent Important Field Safety Notice 618-01-303-026 letter dated June 2017 to all affected customers. The letter identified the affected product, problem, the potential clinical impact and actions to be taken.. It also provides a workaround to avoid the issue. |
| Quantity | 110 units |
| Distribution | Worldwide Distribution in the states of AK, CT, GA, KY, LA, MA, MD, MN, NC, NM, OH, OK, OR, PA, SC, SD, TN, TX, VA, WA and countries of Hawaii Australia, Austria, Belgium, Denmark, France, Germany, Hong Kong, India, Indonesia, Ireland, Italy, Japan, Netherlands, New Zealand, Poland, Slovenia, Spain |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K143485 | iGuide 2.1 Medical Intelligence Medizintechnik GmbH, Mar 4, 2015 |