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Recall Observatory FDA recall evidence

Device product

iGUIDE System with software build iGuide 2.2.0, 2.2.1, and 2.2.2

Z-2230-2019

June 19, 2019

Class II

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

    reason.no_named_rule · v1.0.0

    Potential for iGUIDE to incorrectly monitor the 3D position.