Company:Med Tec Inc
Date of Enforcement Report 2/28/2018
Class lI:
PRODUCT
Protura Software which utilizes Elekta’s iCOM interface: MT6XSM1.4.0, MT6XSM1.4.0-1, MT6XSM1.4.0-2, MT6SXM1.4.0-3, MT6XSM1.5.0-2, MT6XSM1.6.0-1, MT6XSM1.7.2, MT6XSM1.7.2-1, MT6XSM1.7.2-3, MT6XSM1.7.3, MT6XSM1.7.3-1, MT6XSM1.7.3-3. The Protura Software is intended to interface between record and verify systems, linear accelerator (Linac) software systems, and/or image guidance systems and the Protura Couch..
Recall Number Z- 0671-2018
REASON
When an error message remains displayed and is not cleared in the Protura software with the Elekta pedestal coordinates, moving the pedestal could cause the Protura software to not update with the pedestal location and buffers the pedestal movement history.
RECALLING FIRM/MANUFACTURER
Med Tec Inc., Orange City, IA on 11/8/2017. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
5 installations
DISTRIBUTION
US Distribution to Iowa and South Dakota. Shipped internationally to the Netherlands.
___________________________________
