Recall Z-1992-2016— Med Tec Inc

Name: FDA recall Z-1992-2016
Creator: U.S. Food and Drug Administration
Published: 2016-03-31

Class II · Terminated

Class II FDA medical device recall by Med Tec Inc, initiated 2016-03-31, terminated 2017-02-03. It names one FDA 510(k) clearance: K132084. 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. 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..

Recalling firm: Med Tec Inc
Classification: Class II
Status: Terminated
Initiated: 2016-03-31
Terminated: 2017-02-03
Firm location: Orange City, IA, United States

510(k) clearances named in this recall

1 on FDA's record

K132084 — PROTURA COUCH SOFTWAREMed-Tec, Inc. D/B/A Civco Medical Solutions·cleared 2013-09-26

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.