Elekta, Inc.: Medical Device Recall in 2016 - (Recall #: Z-1705-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

iGUIDE System, for patient positioning, with assistance of a 30 Tracking System in a radiotherapy environment.

Product Classification:

Class II

Date Initiated: May 12, 2016

Date Posted: June 1, 2016

Recall Number: Z-1705-2016

Event ID: 74087

Reason for Recall:

If by mistake the initial pre-treatment imaging was performed BEFORE the HexaPOD was moved to the DRIVE (*START) position, iGUIDE offers the possibility to branch into a specific catch-up workflow, which was implemented to use the initial scan data.

Status: Terminated

Product Quantity: 20

Code Information:

Software iGUIDE 2.1 and 2.2

Distribution Pattern:

IL, LA, Austria, Australia, Botswana, Germany, Denmark, France, India, Japan

Voluntary or Mandated:

Voluntary: Firm initiated