TEGRIS System manufactured by MAQUET GMBH in Germany recall: Software Issue
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…
Why was TEGRIS System manufactured by MAQUET GMBH in Germany 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
part number: 1703.35AO, with software version up to 2.1.x.x.
- 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…
- Recalling firm
- Maquet Medical Systems USA
- Quantity
- 6 units
- Distribution
- US Nationwide Distribution including NE, NY and PA.
- Recall date
- January 28, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)