Reported Jan 28, 2015 · Terminated
TEGRIS System manufactured by MAQUET GMBH in Germany The Maquet Tegris OR Integration System is designed to be used as…
Maquet Medical Systems USA
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Maquet Medical Systems USA · 45 Barbour Pond Dr · Wayne, NJ · 07470-2094
Is this the product you have?
- 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 functionsRecording and distribution of images and videos and interaction with medical and non-medical devices
- Lot codes and dates
- part number
1703.35AOwith software version up to 2.1.x.x
- part number
- Amount recalled
- 6 units
Where it was sold
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.
This product could cause temporary or reversible health problems — stop using it.
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