Alyon
ALYON High Definition Dual Light, Accessory Spindle Central Tandem is used with the ALYON Suspension System
11manufacturers in China registered for this device type
41catalogue numbers in this listing
2510(k) clearances naming this product code
6recalls 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 | Steris Corporation, United States |
|---|---|
| FDA product code | FQO |
| Device type | Table, Operating-Room, Ac-Powered |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4960 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2024-02-19 |
| Record revised | 2026-04-21 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ALYON Suspension System | In distribution | |
| ALYON Suspension System | In distribution | |
| ALYON Suspension System | In distribution | |
| ALYON Suspension System | In distribution | |
| ALYON Suspension System | In distribution | |
| ALYON Suspension System | In distribution | |
| ALYON Suspension System | In distribution | |
| ALYON Suspension System | In distribution | |
| ALYON Suspension System | In distribution | |
| ALYON Suspension System | In distribution | |
| ALYON Suspension System | In distribution | |
| ALYON Suspension System | In distribution | |
| ALYON Suspension System | In distribution | |
| ALYON Suspension System | In distribution | |
| ALYON Suspension System | In distribution | |
| ALYON Suspension System | In distribution | |
| ALYON Suspension System | In distribution | |
| ALYON Suspension System | In distribution | |
| ALYON Suspension System | In distribution | |
| ALYON Suspension System | In distribution | |
| ALYON Suspension System | In distribution | |
| ALYON Suspension System | In distribution | |
| ALYON Suspension System | In distribution | |
| ALYON Suspension System | In distribution | |
| ALYON Suspension System | In distribution | |
| ALYON Suspension System | In distribution | |
| ALYON Suspension System | In distribution | |
| ALYON Suspension System | In distribution | |
| ALYON Suspension System | In distribution | |
| ALYON Suspension System | In distribution | |
| ALYON Suspension System | In distribution | |
| ALYON Suspension System | In distribution | |
| ALYON Suspension System | In distribution | |
| ALYON Suspension System | In distribution | |
| ALYON Suspension System | In distribution | |
| ALYON Suspension System | In distribution | |
| ALYON Suspension System | In distribution | |
| ALYON Suspension System | In distribution | |
| ALYON Suspension System | In distribution | |
| ALYON Suspension System | In distribution | |
| ALYON Suspension System | 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 |
| Foot switch | Maquet Gmbh | 23 |
| Amsco | Steris Corporation | 14 |
| Atec A.R.M. | Alphatec Spine, Inc. | 13 |
| Universal table top | Maquet Gmbh | 13 |
| Magnus operating table system | Maquet Gmbh | 8 |
Showing 12 of 442. All products under Table, Operating-Room, Ac-Powered
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K090136 | 2009-03-20 |
| K971307 | 1997-06-27 |
Recalls
2 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 |
|---|---|---|---|---|---|
| 2014-06-27 | Class II | Device Design | STERIS engineering analysis has determined the D1 pressure switch in the hydraulic column manifold does not adequately detect pressure level. If one or more of the table floor lock feet become unlocked due to the loss of hydraulic pressur | 3689 | 2015-09-16 |
| 2011-10-17 | Not classified | Nonconforming Material/Component | Some hydraulic column cylinders installed in certain 5085 and 5085SRT Surgical Tables were assembled by their supplier with incorrect snap rings and an anomaly was present in the tilt cylinder. This error may affect the user’s ability to mo | 167 tables were distributed – 5085=108 and 5085SRT=59 | 2013-03-19 |
| 2010-08-12 | Not classified | Other | Cmax Surgical Tables may lose calibration if the table is operated only on battery power and if the table is in a low battery charge condition. This could result in the table moving into an unexpected tilt position when the Level button is | 1,635 tables | 2012-09-27 |
| 2010-05-14 | Not classified | Nonconforming Material/Component | STERIS has learned that a limited quantity of manifold assemblies were manufactured by our supplier with incorrect washers and springs in the valves of the manifold. This supplier error has the potential to cause: a) an inability to articu | 79 units | 2012-02-24 |
| 2010-02-17 | Class II | Employee error | Customers may be storing objects on the base and/or around the column of the surgical table. This prohibited practice and misuse known by the customers can damage the override switch assembly located at the top of the column cover. Depend | 11,044 Units | 2013-03-13 |
| 2009-05-12 | Not classified | Process control | A limited quantity of the Cmax Hand Controls, P150832-500, were manufactured without Loctite thread locker on the screws that attach the mounting clip to the hand control case. This clip provides a means of storing the hand control on the | 217 Units | 2013-02-26 |
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.