Recall Z-1992-2016 ยท JAI Couch, Radiation Therapy, Powered
Med Tec Inc
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
| Date | Mar 31, 2016 |
| Status | Terminated |
| Reason | When using the recalled product in split shift mode, the non-sub-millimeter positioning has been found to be inconsistent with the setting parameters. |
| Root cause | 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 |
| Quantity | 9 |
| Distribution | Worldwide Distribution - US Distribution including the countries of Switzerland, Germany.. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K132084 | PROTURA COUCH SOFTWARE Med-Tec, Inc. D/B/A Civco Medical Solutions, Sep 26, 2013 |