Med Tec Inc recalls Protura Robotic Couch System Software, versions 1.6.1 (Part Number MT6XSM1.6.1), 1.7.0 (Part Number MT6XSM1.7.0), and 1…

Recall date

March 31, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1992-2016

FDA classification

Class II

Brand / firm

Med Tec Inc

Sold / distributed

Worldwide Distribution - US Distribution including the countries of Switzerland, Germany..

Why it was recalled

When using the recalled product in split shift mode, the non-sub-millimeter positioning has been found to be inconsistent with the setting parameters.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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