Home / Recalls / Med Tec Inc / Z-1992-2016

Z-1992-2016 Class II Terminated

Recalled by Med Tec Inc — Orange City, IA

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)

Other recalls by Med Tec Inc

  • Z-2243-2020 Class II — Type S Extension For use with Varian, CIVCO, Prescription Only - Product Usage: (May 12, 2020)
  • Z-1837-2019 Class II — CIVCO Solstice(TM) SRS Immobilization System, Part Numbers: a) CHS03, b) CHS04 (April 15, 2019)
  • Z-0671-2018 Class II — Protura Software which utilizes Elekta's iCOM interface: MT6XSM1.4.0, MT6XSM1.4. (November 8, 2017)
  • Z-3083-2017 Class II — CIVCO Arm Support, REF 106047, distributed as: (a) Rigid Arm Support, Large, Se (August 10, 2017)
  • Z-3082-2017 Class II — CIVCO Arm Support, REF 106015, distributed as: (a) Rigid Arm Support, Standar (August 10, 2017)
  • Z-2763-2015 Class II — CIVCO Shoulder Retractors, Reusable non-sterile hand grip, REF 302070, packaged (August 19, 2015)
  • Z-0990-2015 Class II — Civco, MTSR03 Shoulder Retractor with Wrist Loops Kit with Base, plus two pairs (December 11, 2014)
  • Z-0989-2015 Class II — Civco, MTSR02 Shoulder Retractor with Sherpa Wrist Loops Kit with Base, Non-ster (December 11, 2014)