Skytron LLC
60" Protective frame only, requires 4VB/4CM, Freedom, aluminum construction
11manufacturers in China registered for this device type
2catalogue numbers in this listing
7recalls 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 | Skytron, LLC, 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 | 2023-04-25 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 4A-PF60-ALU Freedom | In distribution | |
| 40-LC-ED | 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
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 |
|---|---|---|---|---|---|
| 2022-06-02 | Class II | Component design/selection | Under certain circumstances, the mounting screws may loosen or pull out from the attachment point on the Ergon 3 boom when the GCX Channel Mounting Accessory was used with the VST clamp as a monitor mount on the boom. | 731 | |
| 2021-05-11 | Class II | Device Design | Failure of the FS32 Monitor Brackets from the mounting block could potentially loosen over time and eventually detach from the baseplate, result in the display interface dismounting from its attachment point, causing injury to patients or s | 278 units US; 7 units OUS | |
| 2020-03-05 | Class II | Device Design | Potential for the weld to fail at the pivot point of the monitor bracket. This weld failure could cause the display interface and bracket to fall from its mounted location, resulting in injury. | 43 units | |
| 2016-03-28 | Class II | Process design | Potential for the weld to fail at the pivot point of the monitor bracket. This weld failure could cause the display interface and bracket to fall from its mounted location, resulting in injury. | 24 | 2017-07-25 |
| 2015-12-02 | Class II | Device Design | The hardware that holds the VESA plate and the display interface / monitor to the bracket may fail causing the display interface to fall from the bracket. Over time and with use the threaded rod hardware material can weaken and detach from | 286 | 2016-07-19 |
| 2005-08-04 | Not classified | Other | The release levers can inadvertently release under load while the leg section is positioned at a ninety degree angle causing the leg section to drop. | 160 total | 2008-05-01 |
| 2005-08-04 | Not classified | Other | The release levers can inadvertently release under load while the leg section is positioned at a ninety degree angle causing the leg section to drop. | 160 total | 2008-05-01 |
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.