Device product
iGUIDE Software 2.2 Product Usage: Control of accurate patient positioning with assistance of a 30 Tracking System in a radiotherapy environment.
Z-3017-2017
Product summary
- Firm
- Elekta, Inc.
- Event
- Event 77590
- Status
- Terminated
- Classification
- Class II
- Quantity
- 110 units
- Official record key
device-enforcement:Z-3017-2017
Official wording
Reason: Incorrect PEC values.
Code information: Scope; iGUIDE 2.2.0, iGUIDE 2.2.1
Distribution pattern: 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.
Derived failure modes
-
Unknown
Incorrect PEC values.