Z-1992-2016 Class II Terminated
FDA device recall Z-1992-2016 was initiated by Med Tec Inc on March 31, 2016 and is designated Class II. 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. The recall status is terminated (terminated February 3, 2017). Affected quantity: 9.
Recall Details
- Product Type
- Devices
- Report Date
- June 22, 2016
- Initiation Date
- March 31, 2016
- Termination Date
- February 3, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 9
Product Description
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
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.
Distribution Pattern
Worldwide Distribution - US Distribution including the countries of Switzerland, Germany..
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)