Flexis
Catalogue number 0682400500, listed by Stryker Communications, Inc., United States, under Table, Operating-Room, Ac-Powered. 11 manufacturers in China are registered for this product code.
11manufacturers in China registered for this device type
1catalogue number
11recalls 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 | Stryker Communications, 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 | 2023-06-07 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 0682400500 | 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
1 of these is 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 |
|---|---|---|---|---|---|
| 2021-01-29 | Class II | Under Investigation by firm | The manufacturer has become aware that there is a likelihood that the S-Series Equipment Management System Capacitive Touch Controls on the MFRs rotational electrical magnetic brakes may disengage when an electrocautery device is in use. | 1,393 units | |
| 2009-11-13 | Not classified | Other | In certain positions, product is susceptible to fluid instrusion which could possibly result in short circuit or unsolicited movement. | 206 | 2010-08-11 |
| 2009-05-08 | Not classified | Device Design | Potential for health care provider/hospital staff member to sustain injury to fingers or hands when removing/handling the headrest component of the VERTIER Surgical Table. | 230 headrests. | 2010-04-26 |
| 2008-11-13 | Not classified | Nonconforming Material/Component | Surgical tables were produced using an unapproved tilt frame bushing. | 31 | 2009-08-28 |
| 2008-09-05 | Not classified | Device Design | Circlip component used to suspend flat panel and navigation arm system may become dislodged. | 705 units | 2009-10-02 |
| 2008-09-02 | Not classified | Nonconforming Material/Component | Paint chips: Shroud used to cover cables on the Stryker Vision 3 flat panel monitor (monitor used in surgery rooms during procedures) was not manufactured/painted to specification, resulting in the possibility that paint chips could fall of | 116 units. | 2010-01-08 |
| 2008-07-02 | Not classified | Device Design | Hydraulic lines responsible for tilting the surgical table have the potential to be severed when articulating table to its lowest position, possibly resulting in the unexpected and rapid movement of the table. | 52 units. | 2010-01-07 |
| 2008-07-02 | Not classified | Device Design | Hydraulic lines responsible for tilting the surgical table have the potential to be severed when articulating table to its lowest position, possibly resulting in the unexpected and rapid movement of the table. | 4 units. | 2010-01-07 |
| 2008-07-02 | Not classified | Device Design | Hydraulic lines responsible for tilting the surgical table have the potential to be severed when articulating table to its lowest position, possibly resulting in the unexpected and rapid movement of the table. | 16 units. | 2010-01-07 |
| 2008-07-02 | Not classified | Device Design | Hydraulic lines responsible for tilting the surgical table have the potential to be severed when articulating table to its lowest position, possibly resulting in the unexpected and rapid movement of the table. | 18 units. | 2010-01-07 |
| 2008-05-01 | Not classified | Device Design | Potential exists for energy chain, which is responsible for protecting hydraulic and electrical cables during up and down motion on VERTIER Surgical Table, to become lodged between column case sections resulting in possible reduction or los | 10 units. | 2010-01-08 |
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.