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U.S. Department of Health and Human Services

Class 2 Device Recall HexaPOD evo RT System

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  Class 2 Device Recall HexaPOD evo RT System see related information
Date Initiated by Firm August 18, 2016
Date Posted August 30, 2016
Recall Status1 Terminated 3 on May 23, 2017
Recall Number Z-2691-2016
Recall Event ID 74967
510(K)Number K072079  
Product Classification Accelerator, linear, medical - Product Code IYE
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.
Code Information iGuide 2.2.0
Recalling Firm/
Manufacturer		 Elekta, Inc.
400 Perimeter Center Ter NE Ste 50
Atlanta GA 30346-1227
For Additional Information Contact Linda Wetsel
770-300-9725
Manufacturer Reason
for Recall		 Potentially unrecognized incorrect position of the treatment couch in 3D workflow, i.e. the HexaPOD has not moved fully to the 3D position.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action 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.
Quantity in Commerce 13
Distribution Worldwide Distribution - US Nationwide in the states of LA, PA, WA, and the countries of: Australia, Denmark, France, India, Italy, and Japan.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = IYE and Original Applicant = MEDICAL INTELLIGENCE MEDIZINTECHNIK-GMBH-AN ELEKTA
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