Company:Maquet Medical Systems USA
Date of Enforcement Report: 1/28/2015
Class lI:
PRODUCT
TEGRIS System manufactured by MAQUET GMBH in Germany The Maquet Tegris OR Integration System is designed to be used as the cental 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.
Recall Number Z-0993-2015
REASON
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.
RECALLING FIRM/MANUFACTURER
Maquet Medical Systems USA, Wayne, NJ on 8/21/2014 Voluntary: Firm Initiated recall is ongoing
VOLUME OF PRODUCT IN COMMERCE
6
DISTRIBUTION
Nationwide
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