Elekta, Inc.: Medical Device Recall in 2014 - (Recall #: Z-1807-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

iGUIDE System Product Usage: The intended use of the device is the control of accurate patient positioning with the assistance of a 30 Tracking System in a radiotherapy environment.

Product Classification:

Class II

Date Initiated: May 29, 2014

Date Posted: June 25, 2014

Recall Number: Z-1807-2014

Event ID: 68430

Reason for Recall:

A bug in the software prevents the iGUIDE software from logging off.

Status: Terminated

Product Quantity: 224

Code Information:

Software Versions 2.0.0, 2.0.1 and 2.0.2

Distribution Pattern:

Worldwide Distribution - USA (nationwide) in the states of AZ, CA, CT, HI, IL, IA, KY, MD, MA, MI, MO, NH, NJ, NC, ND, OH, OK, OR, PA, TX, VA, WA, WI, and the countries of Algeria, Australia, Austria, Brazil, Canada, China, Colombia, Denmark, Finland, France, Germany, Hong Kong, India, Italy, Japan, Kazakhstan, Mexico, Netherlands, New Zealand, Peru, Poland, Russia, Saudi Arabia, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, United Kingdom and Vietnam

Voluntary or Mandated:

Voluntary: Firm initiated