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HarmonyAIR
STERIS CORPORATION · Model A-Series Lighting System · UDI-DI 00724995188993
10
510(k) clearances
5,203
Adverse events
453
Recalls
67
Facilities
Description
The A-Series Hybrid Dual Light 75-inch Light, 67-inch Light, No Drop Tube, No Controller is used with the HarmonyAIR A-Series Lighting System.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 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 expected to fully detac |
| 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 expected to fully detac |
| 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 light head detaching. |
| 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 light head detaching. |
| 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 light head detaching. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.