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Recall Observatory FDA recall evidence

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

June 19, 2017

Class II

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

    reason.no_named_rule · v1.0.0

    Incorrect PEC values.