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U.S. Department of Health and Human Services

Class 2 Device Recall Elekta ERGO

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  Class 2 Device Recall Elekta ERGO see related information
Date Initiated by Firm September 01, 2017
Create Date December 13, 2017
Recall Status1 Terminated 3 on November 05, 2019
Recall Number Z-0234-2018
Recall Event ID 78665
510(K)Number K080601  
Product Classification System,planning,radiation therapy treatment - Product Code MUJ
Product Elekta ERGO++

Product Usage:
ERGO is often used for stereotactic treatments.
Code Information Version 1.7.3 and higher
Recalling Firm/
Manufacturer		 Elekta Inc
13723 Riverport Dr Ste 100
Maryland Heights MO 63043-4819
For Additional Information Contact
314-993-0003
Manufacturer Reason
for Recall		 Incorrect DICOM mapping of the exported collimator or couch angles from ERGO, which would lead to incorrect rotation of the collimator or couch when using a MLC device for planning.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Elekta sent an Urgent Important Field Safety Notification letter dated September, 2017. The letter identified affected product, problem and actions to be taken. Customers were instructed that a copy of the Important Field Safety Notice is to be kept with the most current labeling and all personnel working with the product should be made aware of the content of the letter. The customers were asked to complete the verification tests and return the Important Field Safety Notice Acknowledgment form to their local Elekta representative as soon as possible but no later than 30 days from receipt. For questions contact your local Elekta Care Support Center.
Quantity in Commerce 182
Distribution Worldwide Distribution - US Nationwide in the states of: VA, CA, TX, MO, NY, WA, NM, MA, FL, CT, OK, SC, MS, NY, GA, NC and the countries of: AUSTRALIA, BANGLADESH, BRAZIL, BULGARIA, CANADA, COLOMBIA, CZECH REPUBLIC, ECUADOR, FRANCE, GERMANY, GREECE, HONG KONG, INDIA, IRELAND, ITALY, JAPAN, JORDAN, MALAYSIA, MEXICO, NETHERLANDS, NEW ZEALAND, PERU, PHILIPPINES, PORTUGAL, RUSSIA, SAUDI ARABIA, SINGAPORE, SOUTH KOREA, SPAIN, TAIWAN, THAILAND, TURKEY, VENEZUELA, and VIETNAM
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 = MUJ and Original Applicant = 3D LINE MEDICAL SYSTEMS S.R.L.
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