ORT100 Table
T2X OR Table V.2, 110470-600
11manufacturers in China registered for this device type
1catalogue number
13recalls on this code
Who Else Makes It
Concentrated in Jiangsu (6), Shanghai (1), Anhui (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Jiangsu Saikang Medical Equipment Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 34 |
| Jiangsu Yongfa Medical Equipment Technology Co., Ltd. | Zhangjiagang | Jiangsu | Manufacturer | 33 |
| Shanghai NO. 2 Medical College Duhang Medical Equipment Factory | Shanghai | Shanghai | Contract manufacturer | 32 |
| Jiangsu Rooe Medical Technology Co., Ltd. | Zhangjiagang | Jiangsu | Manufacturer | 31 |
| Hefei MT Medical Co., Ltd. | Hefei | Anhui | Manufacturer | 23 |
| Jiangsu Keling Medical Appliances Co., Ltd. | Yangzhou | Jiangsu | Contract manufacturer | 23 |
| Hebei Jiede Medical Equipment Co., Ltd. | Hengshui | Hebei | Contract manufacturer | 20 |
| Suzhou Number WIN Medical Technology Co., Ltd. | Zhangjiagang | Jiangsu | Manufacturer | 16 |
| Shandong Deman Medical Equipment Group Co., Ltd. | Jining | Shandong | Manufacturer | 11 |
| Nanchang Micare Medical Equipment Co., Ltd. | Nanchang | Jiangxi | Manufacturer | 8 |
| Nanjing Mindray BIO-Medical Electronics Co., Ltd. | Nanjing | Jiangsu | Manufacturer | 2 |
Record
| Listed by | Imris Imaging, Inc., United States |
|---|---|
| FDA product code | FQO |
| Device type | Table, Operating-Room, Ac-Powered |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4960 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2017-02-28 |
| Record revised | 2025-04-08 (version 3) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ORT100 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| HarmonyAIR | Steris Corporation | 452 |
| Skytron | Skytron, LLC | 200 |
| Table, Operating-Room, Ac-Powered | Steris Corporation | 165 |
| iCE boom and Pendant | Amico Clinical Solutions | 102 |
| Mindray | Nanjing Mindray BIO-Medical Electronics Co., Ltd. | 95 |
| Amtai | Amtai Medical Equipment, Inc. | 95 |
| Steris | Steris Corporation | 72 |
| Alyon | Steris Corporation | 41 |
| Foot switch | Maquet Gmbh | 23 |
| Amsco | Steris Corporation | 14 |
| Atec A.R.M. | Alphatec Spine, Inc. | 13 |
| Universal table top | Maquet Gmbh | 13 |
Showing 12 of 442. All products under Table, Operating-Room, Ac-Powered
Recalls
13 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 | 6 units | |
| 2018-11-06 | Class II | Under Investigation by firm | Table may drift in the roll position while in use | 14 units | 2021-07-25 |
| 2018-11-06 | Class II | Under Investigation by firm | Table may drift in the roll position while in use | 14 units | 2021-07-25 |
| 2018-11-06 | Class II | Under Investigation by firm | Table may drift in the roll position while in use | 15 units | 2021-07-25 |
| 2018-11-06 | Class II | Under Investigation by firm | Table may drift in the roll position while in use | 27 units | 2021-07-25 |
| 2018-02-23 | Class II | Under Investigation by firm | The rotational locking mechanisms on the ORT 200/300 tables fail to operate such that it cannot change states between locked and unlocked. | 17 units | 2019-08-27 |
| 2018-02-23 | Class II | Under Investigation by firm | The rotational locking mechanisms on the ORT 200/300 tables fail to operate such that it cannot change states between locked and unlocked. | 13 units | 2019-08-27 |
| 2018-02-23 | Class II | Other | The Operating Room Table may drift while in use, which could potentially result in unintended movement of the table. | 17 units | 2019-09-12 |
| 2018-02-23 | Class II | Other | The Operating Room Table may drift while in use, which could potentially result in unintended movement of the table. | 14 units | 2019-09-12 |
| 2018-02-23 | Class II | Other | The Operating Room Table may drift while in use, which could potentially result in unintended movement of the table. | 26 units | 2019-09-12 |
| 2018-02-23 | Class II | Other | The Operating Room Table may drift while in use, which could potentially result in unintended movement of the table. | 13 units | 2019-09-12 |
| 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. | 16 tables | 2019-08-27 |
| 2014-10-01 | Class II | Use error | One of the three pins that is used to hold the ORT200 table alignment block in place on the floor of the MR Suite went missing during testing at a health care facility. | 14 | 2015-02-20 |
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.