Light, Surgical, Fiberoptic
FDA adverse event reports and recall history for light, surgical, fiberoptic (product code FST), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 310
- Deaths
- 0
- Injuries
- 43
- Malfunctions
- 246
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
- 2015-01-07TerminatedSoftware Design Change
Harmony vLED Surgical Lighting System, one unit packaged per box The Harmony vLED Surgical Lighting System 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.
STERIS has learned that groups of LED lights (modules) contained within the vLED light head may illuminate inconsistently.
- 2012-07-18TerminatedDevice Design
GMF-RC65 Replacement Surgical Headlight Cable for Cogent Microlink. GMF-RC65 Replacement Surgical Headlight Cable for Cogent Microlink is used to transmit light.
The GMF-RC65 Replacement Surgical Headlight Cable for Cogent Microlink falls outside of the firm's 510k due to light transmitting fiber material difference.
- 2012-01-20TerminatedProcess control
Surgical Headlight labeled in part *Gulf Medical Fiberoptics*OLDSMAR, FLORIDA U.S.A.* Model Numbers: GMF-H001, GMF-H100, GMF-H101, GMF-H102, GMF-H103, GMF-H104, GMF-H105, and GMF-H106. The Surgical Headlight is a passive luminaire. It is illuminated by a source of light by way of the fiber optics and provides supplemental lighting for medical and surgical procedures.
Gulf Medical Fiberoptics, Inc. recalled their Surgical Headlight because the cleaning instructions for the exterior surfaces of the headlight , headgear and fiber cable with 70% isopropyl alcohol had not been validated.
- 2012-01-11TerminatedDevice Design
Luxtec UltraLite Pro Headlight with 9ft bifurcated cable Model: AX2000BIF Product Usage: The fiber optic headlight system Is designed to deliver illumination from a high intensity light source for surgical site illumination.
Headlight assembly (module) may become loose and separate from the headband assembly
- 2012-01-11TerminatedDevice Design
Luxtec UltraLite Headlight System with 9ft premium bifurcated cable Model: AX2100BIF Product Usage: The fiber optic headlight system Is designed to deliver illumination from a high intensity light source for surgical site illumination.
Headlight assembly (module) may become loose and separate from the headband assembly
- 2012-01-11TerminatedDevice Design
Luxtec UltraLite Headlight System Headband Model: AXI375BIF Product Usage: The fiber optic headlight system Is designed to deliver illumination from a high intensity light source for surgical site illumination.
Headlight assembly (module) may become loose and separate from the headband assembly
- 2012-01-11TerminatedDevice Design
Luxtec UltraLite Headlight System with short linkage Model: AX 1375BIFSL Product Usage: The fiber optic headlight system Is designed to deliver illumination from a high intensity light source for surgical site illumination.
Headlight assembly (module) may become loose and separate from the headband assembly
- 2012-01-11TerminatedDevice Design
Luxtec UltraLite Headlight System sweatband Model: AXI385BIF Product Usage: The fiber optic headlight system Is designed to deliver illumination from a high intensity light source for surgical site illumination.
Headlight assembly (module) may become loose and separate from the headband assembly
- 2012-01-11TerminatedDevice Design
Luxtec UltraLite Headlight System sweatband with short linkage Model: AXI385BIFSL Product Usage: The fiber optic headlight system Is designed to deliver illumination from a high intensity light source for surgical site illumination.
Headlight assembly (module) may become loose and separate from the headband assembly
- 2012-01-11TerminatedDevice Design
Mark II Headlight module-black Model: 001380LX Product Usage: The fiber optic headlight system Is designed to deliver illumination from a high intensity light source for surgical site illumination.
Headlight assembly (module) may become loose and separate from the headband assembly
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