—#148905

Product

HexaPOD evo RT System Product Usage: The intended use of the device is the control of accurate patient positioning with assistance of a 3D Tracking System in a radiotherapy environment.

FDA product code: IYE — Accelerator, Linear, Medical
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K072079
Affected lot / code info: iGuide 2.2.0

Why it was recalled

Potentially unrecognized incorrect position of the treatment couch in 3D workflow, i.e. the HexaPOD has not moved fully to the 3D position.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

Elekta sent an Important User Notice 618-03-303-025 to affected customers on 8/18/2016. The notice identified the affected product, problem, clinical impact, solution and actions to be taken. The Notice reminds users that the Interlock Check is not possible during 3D Workflow as iGUIDE is not in use. The notice reminds users that if iGUIDE is not being used - (A) Ensure the HexaPOD is at its pre-defined 3D position before treatment, and (B) Ensure the External Inhibit LED at the EnableSwitch Board is off. For questions contact your local Elekta office.

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution - US Nationwide in the states of LA, PA, WA, and the countries of: Australia, Denmark, France, India, Italy, and Japan.

Timeline

Recall initiated: 2016-08-18
Posted by FDA: 2016-08-30
Terminated: 2017-05-23
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #148905. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.