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U.S. Department of Health and Human Services

Class 2 Device Recall Protura Robotic Couch System Software, versions 1.6.1, 1.7.0, and 1.7.1

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  Class 2 Device Recall Protura Robotic Couch System Software, versions 1.6.1, 1.7.0, and 1.7.1 see related information
Date Initiated by Firm March 31, 2016
Create Date June 15, 2016
Recall Status1 Terminated 3 on February 03, 2017
Recall Number Z-1992-2016
Recall Event ID 73692
510(K)Number K132084  
Product Classification Couch, radiation therapy, powered - Product Code JAI
Product Protura Robotic Couch System Software, versions 1.6.1 (Part Number MT6XSM1.6.1), 1.7.0 (Part Number MT6XSM1.7.0), and 1.7.1 (Part Number MT6XSM1.7.1), CIVCO, Orange City, IA 51041
Code Information Versions 1.6.1 (Part Number MT6XSM1.6.1), 1.7.0 (Part Number MT6XSM1.7.0), and 1.7.1 (Part Number MT6XSM1.7.1)
Recalling Firm/
Manufacturer		 Med Tec Inc
PO Box 320
1401 8th St SE
Orange City IA 51041-7463
For Additional Information Contact Jim Leong
712-737-8688
Manufacturer Reason
for Recall		 When using the recalled product in split shift mode, the non-sub-millimeter positioning has been found to be inconsistent with the setting parameters.
FDA Determined
Cause 2		 Software design
Action Civco Medical Solutions sent a "Urgent Field Correction Notice" dated March 31, 2016, to all affected customers. The letter identified the product the problem and the action need to be taken by the customer. The software's other configuration, "All 6 Degrees Protura" does not have the same translational issues. The firm send notification letters on February 23, 2016. In this letter, the Product Manager verified each site's software is configured to this operational mode which operates without the identified problem. In a later and separate notification on March 31, 2016, the firm informed customers that a new software version will be installed to address the problem. No timeframe was given in the letter. For further questions, please call ( 712) 737-8688.
Quantity in Commerce 9
Distribution Worldwide Distribution - US Distribution including the countries of Switzerland, Germany..
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 = JAI and Original Applicant = MED-TEC, INC. D/B/A CIVCO MEDICAL SOLUTIONS
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