Z-3017-2017 Class II Terminated
FDA device recall Z-3017-2017 was initiated by Elekta, Inc. on June 19, 2017 and is designated Class II. Reason for recall: Incorrect PEC values. The recall status is terminated (terminated November 5, 2019). Affected quantity: 110 units.
Recall Details
- Product Type
- Devices
- Report Date
- August 16, 2017
- Initiation Date
- June 19, 2017
- Termination Date
- November 5, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 110 units
Product Description
iGUIDE Software 2.2 Product Usage: Control of accurate patient positioning with assistance of a 30 Tracking System in a radiotherapy environment.
Reason for Recall
Incorrect PEC values.
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.
Code Information
Scope; iGUIDE 2.2.0, iGUIDE 2.2.1