Visum Blade, Isuite
Visum Blade light Head Assembly, 9 Pole
5manufacturers in China registered for this device type
1catalogue number
2510(k) clearances naming this product code
18recalls on this code
Who Else Makes It
Concentrated in Guangdong (2), Shandong (1), Jiangxi (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen Kaiyan Medical Equipment Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 17 |
| Beijing Aeonmed Co., Ltd. | Sanhe | Hebei | Contract manufacturer | 7 |
| Guangdong Kareway Medical Technology Co., Ltd. | Foshan | Guangdong | Manufacturer | 16 |
| Shandong Deman Medical Equipment Group Co., Ltd. | Jining | Shandong | Manufacturer | 11 |
| Nanchang Micare Medical Equipment Co., Ltd. | Nanchang | Jiangxi | Manufacturer | 8 |
Record
| Listed by | Stryker Communications, Inc., United States |
|---|---|
| FDA product code | FSY |
| Device type | Light, Surgical, Ceiling Mounted |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4580 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2016-09-30 |
| Record revised | 2021-01-08 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| P22309 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| HarmonyAIR | Steris Corporation | 1,344 |
| Volista | Maquet Gmbh | 677 |
| iCE Surgical Light | Amico Clinical Solutions | 599 |
| Powerled TM | Maquet Gmbh | 287 |
| Devon | Cardinal Health | 70 |
| Light, Surgical, Ceiling Mounted | Maquet Gmbh | 68 |
| Alyon | Steris Corporation | 64 |
| Medical Boom | Amico Clinical Solutions | 56 |
| Standop Volista® | Maquet Gmbh | 50 |
| Amtai | Amtai Medical Equipment, Inc. | 45 |
| Mira Minor Surgery Light | Amico Lights Corporation | 24 |
| MI Product Line | Medical Illumination International, Inc | 20 |
Showing 12 of 191. All products under Light, Surgical, Ceiling Mounted
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K132747 | 2013-12-30 |
| K060802 | 2006-04-07 |
Recalls
12 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 |
|---|---|---|---|---|---|
| 2026-02-23 | Class II | Unknown/Undetermined by firm | Surgical light assembly may not adequate support the weight of the ceiling cover. | 6170 units | |
| 2025-07-15 | Class II | Component change control | Surgical lights have stress lines forming on the powder coating, which indicates that powder coating chipping can occur. | 40 | |
| 2024-02-08 | Class II | Employee error | Due to insufficient mounting force the stability of surgical light system cannot be guaranteed. | 1 unit | |
| 2019-10-11 | Class II | Other | The firm has become aware that there is a likelihood that a missing snap ring or spanner nut may result in an insufficient mount force that causes the surgical light to fall. If the suspension of the surgical light falls, it may potentially | 1415 Surgical Lights | 2022-10-18 |
| 2019-08-01 | Class II | Process control | The mounts on the monitor may have an insufficient weld. | 52 devices | 2021-04-27 |
| 2019-03-22 | Class II | Employee error | The back cover of the light head was insufficiently assembled and could potentially fall off the light. | 3,344 lights | |
| 2019-03-22 | Class II | Employee error | The back cover of the light head was insufficiently assembled and could potentially fall off the light. | 946 lights | |
| 2018-11-13 | Class II | Employee error | There is a potential the joint in the suspension of the device is insufficiently assembled. | 3,176 devices | |
| 2018-01-29 | Class II | Employee error | The device could have a missing spanner nut and snap ring which could potentially result in the equipment falling. | 1,162 devices | 2019-07-08 |
| 2018-01-26 | Class II | Process control | The mounts on the monitor may have an insufficient (missing or incomplete) weld. | 850 | 2019-03-19 |
| 2017-02-28 | Class II | Device Design | The potential hazard that can arise for the combination of the missing screws and the overloading by the end user is insufficient mount force that causes the equipment to fall. | 292 devices (in US) | 2018-01-08 |
| 2012-09-25 | Class II | Equipment maintenance | Stryker has become aware that there is a low likelihood of incomplete engagement of the Spring Arm Circlip during service or replacement of the Spring Arm. If the Spring Arm Circlip is not fully seated, the Spring Arm could separate and fal | United States: 1,082 units and Outside United States: 199 un | 2013-04-22 |
| 2011-11-07 | Not classified | Nonconforming Material/Component | Stryker has identified a potential structural issue with the Visum LED surgical light(s). During a complaint investigation, Stryker became aware that there was a possibility that incorrect assembly could result in the light head beginning | 1143 Devices | 2012-08-17 |
| 2011-08-23 | Not classified | Process control | Installation records for the SwitchPoint Infinity, Booms, Lights, and Flat Panel systems are incomplete or inadequate. | 2012-08-20 | |
| 2011-08-23 | Not classified | Process control | Installation records for the SwitchPoint Infinity, Booms, Lights, and Flat Panel systems are incomplete or inadequate. | 2012-08-20 | |
| 2010-04-15 | Not classified | Employee error | Installation records are incomplete. | 608 (booms and lights) | 2011-01-24 |
| 2010-04-15 | Not classified | Employee error | Installation records are incomplete. | 608 (all lights and booms) | 2011-01-24 |
| 2010-04-15 | Not classified | Employee error | Installation records are incomplete. | 608 (lights and booms) | 2011-01-24 |
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.