iGUIDE Software 2.2 Product Usage: Control of accurate patient positioning with assistance of a 30 Tracking System in a radiotherapy environment.
This recall has been terminated (originally issued June 19, 2017).
- Company
- Elekta, Inc.
- Recall Initiated
- June 19, 2017
- Terminated
- November 5, 2019
- Recall Number
- Z-3017-2017
- Quantity
- 110 units
- Firm Location
- Atlanta, GA
- Official Source
- View on FDA website ↗
Reason for Recall
Incorrect PEC values.
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, Sweden, Switzerland, United Kingdom, & Vietnam.
Lot / Code Info
Scope; iGUIDE 2.2.0, iGUIDE 2.2.1
Root Cause
Unknown/Undetermined by firm
Action Taken
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.