—#156700

Product

iGUIDE Software 2.2 Product Usage: Control of accurate patient positioning with assistance of a 30 Tracking System in a radiotherapy environment.

FDA product code: IYE — Accelerator, Linear, Medical
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K143485
Affected lot / code info: Scope; iGUIDE 2.2.0, iGUIDE 2.2.1

Why it was recalled

Incorrect PEC values.

Root cause (FDA determination)

Unknown/Undetermined by firm

Action the firm took

Elekta sent an Urgent Important Field Safety Notice 618-01-303-026 letter dated June 2017 to all affected customers. The letter identified the affected product, problem, the potential clinical impact and actions to be taken.. It also provides a workaround to avoid the issue.

Recalling firm

Firm: Elekta, Inc.
Address: 400 Perimeter Center Ter NE, Ste 50, Atlanta, Georgia 30346-1227

Distribution

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.

Timeline

Recall initiated: 2017-06-19
Terminated: 2019-11-05
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #156700. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.