FDA Enforcement
Class II
Terminated
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.
Recall: Z-0993-2015
·
Reported January 28, 2015
Enforcement
- Recall Number
- Z-0993-2015
- Event ID
- 69560
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Maquet Medical Systems USA
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- January 28, 2015
- Initiation Date
- August 21, 2014
- Classification Date
- January 16, 2015
- Termination Date
- November 17, 2015
- Address
- 45 Barbour Pond Dr, N/A, Wayne, NJ, 07470-2094, United States
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
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.
Code Info
part number: 1703.35AO, with software version up to 2.1.x.x.
Distribution
US Nationwide Distribution including NE, NY and PA.
Quantity
6 units