Device product
iGUIDE System with software build iGuide 2.2.0, 2.2.1, and 2.2.2
Z-2230-2019
Product summary
- Firm
- Elekta, Inc.
- Event
- Event 83180
- Status
- Terminated
- Classification
- Class II
- Quantity
- 374 devices
- Official record key
device-enforcement:Z-2230-2019
Official wording
Reason: Potential for iGUIDE to incorrectly monitor the 3D position.
Code information: Version 2.2.0, Product Code/GTIN Number: 04056719001704; Version 2.2.1, Product Code/GTIN Number: 04056719001742; Version 2.2.2, Product Code/GTIN Number: 04056719002039
Distribution pattern: 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, Czech Republic, Denmark, Egypt, France, Germany, Hong Kong, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Korea, Republic of, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Norway, Poland, Portugal, Romania, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, Vietnam.
Derived failure modes
-
Unknown
Potential for iGUIDE to incorrectly monitor the 3D position.