ORT 400 (Trumpf TruSystem 7500 MR) Table
ORT 400 (Trumpf TruSystem 7500 MR) table Assembly, 119493-000
4manufacturers in China registered for this device type
1catalogue number
5recalls on this code
Who Else Makes It
Concentrated in Beijing (1), Shanghai (1), Tianjin (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| GE Healthcare (China) Co., Ltd. | Beijing | Beijing | Specification developer | 22 |
| Carestream Health, Inc., Global R&D Center | Shanghai | Shanghai | Specification developer | 8 |
| GE Healthcare (Tianjin) Company Limited | Tianjin | Tianjin | Specification developer | 5 |
| Baxter Medical Systems (Suzhou) Co., Ltd. | Taicang | Jiangsu | Contract manufacturer | 4 |
Record
| Listed by | Imris Imaging, Inc., United States |
|---|---|
| FDA product code | KXJ |
| Device type | Table, Radiologic |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1980 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2017-11-20 |
| Record revised | 2025-04-08 (version 3) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ORT 400 (Trumpf TruSystem 7500 MR) table | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Tidi | Tidi Products, LLC | 1,329 |
| Table, Radiologic | Domico Med-Device, LLC | 351 |
| Hillrom™ | Baxter Medical Systems GmbH + Co. KG | 167 |
| Trumpf Medical | Baxter Medical Systems GmbH + Co. KG | 118 |
| Scancoat | Domico Med-Device, LLC | 82 |
| Gems | Tidi Products, LLC | 71 |
| Pads | Baxter Medical Systems GmbH + Co. KG | 41 |
| Bone Foam | Tidi Products, LLC | 25 |
| TS 7500 | Baxter Medical Systems GmbH + Co. KG | 21 |
| Orthopedic Extension | Baxter Medical Systems GmbH + Co. KG | 19 |
| Bionix | Tidi Products, LLC | 16 |
| Control Units | Baxter Medical Systems GmbH + Co. KG | 11 |
Showing 12 of 107. All products under Table, Radiologic
Recalls
5 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2026-08-06 | Class II | Nonconforming Material/Component | The linear actuator and rotational lock mechanism components may experience a mechanical failure that prevents the system from transitioning between locked and unlocked state. This may pose a risk of injury to the patient if unintended rota | 13 units | |
| 2021-08-25 | Class II | Device Design | ORT200/300 rotational lock may fail to function such that it cannot change states between locked and unlocked, due to a mechanical hardware issue. | 10 units | 2024-04-30 |
| 2021-08-25 | Class II | Device Design | ORT200/300 rotational lock may fail to function such that it cannot change states between locked and unlocked, due to a mechanical hardware issue. | 3 units | 2024-04-30 |
| 2021-08-25 | Class II | Device Design | ORT200/300 rotational lock may fail to function such that it cannot change states between locked and unlocked, due to a mechanical hardware issue. | 13 units | 2024-04-30 |
| 2018-02-20 | Class II | Device Design | The rotational locking mechanisms on the ORT 100/ T2X tables can become disengaged or unlocked while in use which could potentially result in unintended movement of the table. | 15 tables | 2019-08-27 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.