TEGRIS System manufactured by MAQUET GMBH in Germany The Maquet… — Class II medical device recall Z-0993-2015
Terminated recall by Maquet Medical Systems USA, reported 2015-01-28, distributed nationwide. The wrong movement results on the MAGNUS OR table. The button commands on the TEGRIS touchscreen for Lower Leg
| Recall number | Z-0993-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Maquet Medical Systems USA, Wayne, NJ, United States |
| Recall initiated | 2014-08-21 |
| Classified | 2015-01-16 |
| Reported by FDA | 2015-01-28 |
| Terminated | 2015-11-17 |
| Distributed | Nationwide (US) |
| Quantity | 6 units |
| Reason classes | software |
| Model numbers | 1703.35AO |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0993-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.