Light, Surgical, Ceiling Mounted
FDA adverse event reports and recall history for light, surgical, ceiling mounted (product code FSY), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 5,195
- Deaths
- 0
- Injuries
- 157
- Malfunctions
- 4,760
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2026-06-15Open, ClassifiedProcess change control
HarmonyAIR A-Series Surgical Lighting System
There is a potential for paint delamination (chipping/peeling) on the lighting system's light heads.
- 2026-06-15Open, ClassifiedMaterial/Component Contamination
HarmonyAIR A-Series Surgical Lighting System
The the plus and minus buttons (+/-) used to control light intensity on the light heads may detach.
- 2026-06-15Open, ClassifiedMaterial/Component Contamination
ALYON Surgical Lighting System
The the plus and minus buttons (+/-) used to control light intensity on the light heads may detach.
- 2026-03-27Open, ClassifiedUnknown/Undetermined by firm
Stryker CHROMOPHARE Softlit Ring Surgical Light System REF: CH00000001
Surgical light assembly may not adequate support the weight of the ceiling cover.
- 2025-09-24Open, ClassifiedComponent change control
Chromophare Surgical Light System, REF: CH00000001; SLX to Oculan NFC Upgrade Kit, REF: P60034
Surgical lights have stress lines forming on the powder coating, which indicates that powder coating chipping can occur.
- 2025-07-25Open, ClassifiedProcess control
Dual Flat Panel Monitor (DFPM) accessories for HarmonyAIR A-Series Surgical Lighting Systems
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.
- 2025-07-25Open, ClassifiedProcess control
Dual Flat Panel Monitor (DFPM) accessories for HarmonyAIR E-Series Surgical Lighting Systems
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.
- 2024-08-14Open, ClassifiedProcess control
Aurora Series, Aurora 7 lighthead; Models: LED7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.
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.
- 2024-08-14Open, ClassifiedProcess control
Aurora 2 Series, Aurora 7 lighthead; Models: AUR7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.
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.
- 2024-08-14Open, ClassifiedProcess control
Aurora 3 Series, Aurora 7 lighthead; Models: AUT7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.
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.
Monitor light, surgical, ceiling mounted automatically
DeviceWatch watches FDA adverse events and recalls for the products you care about, summarizes clinical narratives with AI and alerts you when a safety signal emerges.