Recall Z-0993-2015— Maquet Medical Systems USA
Class II · Terminated
Class II FDA medical device recall by Maquet Medical Systems USA, initiated 2014-08-21, terminated 2015-11-17. FDA's recall record names no specific 510(k) clearance for this event. Product: 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.. 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
- Maquet Medical Systems USA
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-08-21
- Terminated
- 2015-11-17
- Firm location
- Wayne, NJ, United States
Product description
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.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.