Home › Device types › FSY
Light, Surgical, Ceiling Mounted
FDA product code FSY · Class 2 · General, Plastic Surgery
3,794
Registered devices
5,230
Adverse events
454
Recalls
74
510(k) clearances
Devices with this code
HarmonyAIR — STERIS CORPORATIONPOWERLED TM — MAQUET SASSTANDOP VOLISTA® — MAQUET SASHarmonyAIR — STERIS CORPORATIONiCE Surgical Light — Amico Clinical Solutions CorpHarmonyAIR — STERIS CORPORATIONHarmony — STERIS CORPORATIONPOWERLED TM — MAQUET SASiCE Surgical Light — Amico Clinical Solutions CorpSim.LED 450 MC 5p LC — S.I.M.E.O.N. Medical GmbH & Co. KGVolista — MAQUET SASDevon — Cardinal Health, Inc.HarmonyAIR — STERIS CORPORATIONiCE Surgical Light — Amico Clinical Solutions CorpPOWERLED TM — MAQUET SASSTANDOP VOLISTA® — MAQUET SASHarmonyAIR — STERIS CORPORATIONDevon — Cardinal Health, Inc.Volista — MAQUET SASHarmonyAIR — STERIS CORPORATIONHarmonyAIR — STERIS CORPORATIONHarmonyAIR — STERIS CORPORATIONPOWERLED TM — MAQUET SASiCE Surgical Light — Amico Clinical Solutions Corp
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-08-07 | Maquet SAS | The potential for the device to detach at the junction between the spring arm and suspension arm and fall causing potential injury. |
| 2026-05-15 | Steris Corporation | There is a potential for paint delamination (chipping/peeling) on the lighting system's light heads. |
| 2026-05-15 | Steris Corporation | The the plus and minus buttons (+/-) used to control light intensity on the light heads may detach. |
| 2026-05-15 | Steris Corporation | The the plus and minus buttons (+/-) used to control light intensity on the light heads may detach. |
| 2026-02-23 | Stryker Communications | Surgical light assembly may not adequate support the weight of the ceiling cover. |
| 2025-07-15 | Stryker Communications | Surgical lights have stress lines forming on the powder coating, which indicates that powder coating chipping can occur. |
| 2025-06-23 | Steris Corporation | 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 exp |
| 2025-06-23 | Steris Corporation | 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 exp |
| 2024-07-09 | DKK Dai-Ichi Shomei Co., Ltd. | The weld on the light head frame can crack which could lead to problems such as the light head frame sagging, the plastic front face housing cracking, or the li |
| 2024-07-09 | DKK Dai-Ichi Shomei Co., Ltd. | The weld on the light head frame can crack which could lead to problems such as the light head frame sagging, the plastic front face housing cracking, or the li |
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