Elekta, Inc.: Medical Device Recall in 2017 - (Recall #: Z-3017-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: June 19, 2017

Date Posted: August 16, 2017

Recall Number: Z-3017-2017

Event ID: 77590

Reason for Recall:

Incorrect PEC values.

Status: Terminated

Product Quantity: 110 units

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.

Voluntary or Mandated:

Voluntary: Firm initiated