Alphamaxx Mobile Operating Table
4 catalogue numbers from 113322B4, listed by Maquet Gmbh, Germany, under Table, Operating-Room, Ac-Powered. 11 manufacturers in China are registered for this product code.
11manufacturers in China registered for this device type
4catalogue numbers in this listing
3recalls 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 | Maquet Gmbh, Germany |
|---|---|
| FDA product code | FQO |
| Device type | Table, Operating-Room, Ac-Powered |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4960 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-09-22 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 113322B4 | In distribution | |
| 113322F5 | In distribution | |
| 113322F4 | In distribution | |
| 113322B5 | 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 Naming This Product
3 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Getinge Usa Sales Inc | UDI-DI | 2024-05-29 | Class II | Component design/selection | The recall is prompted by a defective charger unit (0970.2873) for models 1133.22B4, 1133.22B5, and 1133.22F5 of the ALPHAMAXX mobile operating table. This issue poses a risk of inadequate charging and operational failure. | 73 units |
| Getinge Usa Sales Inc | UDI-DI | 2024-05-29 | Class II | Component design/selection | The recall is prompted by a defective charger unit (0970.2873) for models 1133.22B4, 1133.22B5, and 1133.22F5 of the ALPHAMAXX mobile operating table. This issue poses a risk of inadequate charging and operational failure. | 171 Units |
| Getinge Usa Sales Inc | UDI-DI | 2024-05-29 | Class II | Component design/selection | The recall is prompted by a defective charger unit (0970.2873) for models 1133.22B4, 1133.22B5, and 1133.22F5 of the ALPHAMAXX mobile operating table. This issue poses a risk of inadequate charging and operational failure. | 7 units |
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 |
|---|---|---|---|---|---|
| 2025-07-14 | Class II | Under Investigation by firm | Under certain conditions, such as the simultaneous use of the operating table with other medical devices, including high-frequency (HF) surgical equipment, interference may occur that could prevent the device from performing as intended. If | 315 units (8 US, 307 OUS) | |
| 2008-09-26 | Not classified | Other | During installation or cleaning there is a risk of crushing the finger by handling the head rest in the area of the gas strut while simultaneously actuating the release lever. | 88 units in US; 1884 units worldwide | 2009-04-16 |
| 2008-09-16 | Not classified | Equipment maintenance | Table tilts: The Alphastar Surgical Table piston rod head may break and cause a full inclination of the table top during Trendelenberg positioning if there is insufficient lubrication. | 141 in US | 2010-01-12 |
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.