HarmonyAIR
The HarmonyAIR Surgical Lighting System G-Series is a variable pattern, variable intensity surgical lighting fixture designed to provide visible illumination of the surgical field or the…
The HarmonyAIR Surgical Lighting System G-Series is a variable pattern, variable intensity surgical lighting fixture designed to provide visible illumination of the surgical field or the patient for the operating room staff.
5manufacturers in China registered for this device type
1,344catalogue numbers in this listing
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 |
| Premarket notification | Exempt |
| Record published | 2020-05-29 |
| Record revised | 2025-01-28 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Over the counter | Yes |
| Label carries | manufacturing date, serial number |
| Distribution end date | 2026-02-13 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| A-Series Lighting System | In distribution | |
| A-Series Lighting System | In distribution | |
| A-Series Lighting System | In distribution | |
| A-Series Lighting System | In distribution | |
| A-Series Lighting System | In distribution | |
| A-Series Lighting System | In distribution | |
| G-Series Surgical Lighting System | In distribution | |
| A-Series Lighting System | In distribution | |
| A-Series Lighting System | In distribution | |
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| A-Series Lighting System | In distribution | |
| A-Series Lighting System | In distribution | |
| G-Series Surgical Lighting System | In distribution | |
| A-Series Lighting System | In distribution | |
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| G-Series Lighting System | In distribution | |
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| G-Series Surgical Lighting System | In distribution | |
| A-Series Lighting System | In distribution | |
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| M-Series Surgical Lighting System | In distribution | |
| A-Series Lighting System | In distribution | |
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Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| Kenex | Kenex (Electro-Medical) Ltd. | 18 |
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
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 |
|---|---|---|---|---|---|---|
| Steris Corporation | UDI-DI | 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 |
| Steris Corporation | UDI-DI | 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 |
| Steris Corporation | UDI-DI | 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 |
Recalls
3 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 | Material/Component Contamination | The the plus and minus buttons (+/-) used to control light intensity on the light heads may detach. | 549 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 |
| 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 |
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.