Maquet Medical Systems USA recalls TEGRIS System manufactured by MAQUET GMBH in Germany The Maquet Tegris OR Integration System is designed to be used as…

Recall date

August 21, 2014

Source

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

Recall number

Z-0993-2015

FDA classification

Class II

Brand / firm

Maquet Medical Systems USA

Sold / distributed

US Nationwide Distribution including NE, NY and PA.

Why it was recalled

The wrong movement results on the MAGNUS OR table. The button commands on the TEGRIS touchscreen for Lower Leg Up and Upper Leg Down are switched in the software for the integration with the MAGNUS operating table system.

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

What was recalled

TEGRIS System manufactured by MAQUET GMBH in Germany The Maquet Tegris OR Integration System is designed to be used as the central operating unit in an operating room. The integration system has two main functions: Recording and distribution of images and videos and interaction with medical and non-medical devices.