Recall record at a glance
| Official record | Z-0993-2015 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Maquet Medical Systems USA |
| Report date | Jan 28, 2015 |
| Recall initiation date | Aug 21, 2014 |
| Quantity | 6 units |
| Location | Wayne, NJ, United States |
Official 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.
Why the product 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.
Distribution information
US Nationwide Distribution including NE, NY and PA.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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