| Class 2 Device Recall Protura Robotic Couch System Software, versions 1.6.1, 1.7.0, and 1.7.1 | |
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
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = JAI
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