Harmony
Ceiling supported surgical lighting system consisting of one or more LED lightheads.
5manufacturers in China registered for this device type
1catalogue number
1510(k) clearance
7recalls 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 | Steris Corporation, United States |
|---|---|
| FDA product code | FSY |
| Device type | Light, Surgical, Ceiling Mounted |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4580 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K072072 |
| Record published | 2016-09-06 |
| Record revised | 2025-01-28 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
| Distribution end date | 2025-01-27 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| LED Surgical Lighting System | Withdrawn |
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 |
|---|---|
| K072072 | 2007-10-05 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Steris Corporation | 510(k) number | 2011-02-18 | Not classified | Other | The arm adapter does not contain labelling specifying the applicable weight and moment limitations of the arm adapter | 14 Units | 2013-03-13 |
Recalls
6 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 |
|---|---|---|---|---|---|
| 2026-05-15 | Class II | Process change control | There is a potential for paint delamination (chipping/peeling) on the lighting system’s light heads. | 4138 units | |
| 2026-05-15 | Class II | Material/Component Contamination | The the plus and minus buttons (+/-) used to control light intensity on the light heads may detach. | 549 units | |
| 2026-05-15 | Class II | Material/Component Contamination | The the plus and minus buttons (+/-) used to control light intensity on the light heads may detach. | 2101 units | |
| 2025-06-23 | Class II | Process control | The DFPM yoke assembly (“yoke assembly”) may detach from the spring arm. Should the yoke assembly detach from the spring arm, the yoke assembly would not be expected to fully detach but rather hang from the wiring within the yoke assembly. | 167 units | |
| 2025-06-23 | Class II | Process control | The DFPM yoke assembly (“yoke assembly”) may detach from the spring arm. Should the yoke assembly detach from the spring arm, the yoke assembly would not be expected to fully detach but rather hang from the wiring within the yoke assembly. | 59 units | |
| 2014-04-04 | Class II | Device Design | Potential for the welded seam in affected monitor spring arms to crack and/or break. | 68 units | 2014-10-15 |
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.