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I-Tek I-150 LED Light Source

I-TEK MEDICAL SOLUTIONS, INC. · Model I-150 · UDI-DI 00869836000307

FCW

510(k) clearances

2,959

Adverse events (1 deaths)

Recalls

Facilities

Description

The LED Light Source is the light source for use with the Medical Illumination Light Enhancement System. It is a compact size with a small footprint, light, easily portable, has infinitely variable light output and is maintenance free with a long lifetime expectancy.

Recalls

Date	Firm	Reason
2023-03-02	Stryker Corporation	Fiber optic cables assembled with not enough epoxy on the proximal end, creating light output issues, which could cause a clinical delay or procedure being converted to open.
2011-10-14	Integra LifeSciences Corp.	A loose screw may result in shifting of components and improper function of the turret or actuator assembly.
2011-10-14	Integra LifeSciences Corp.	A loose screw may result in shifting of components and improper function of the turret or actuator assembly.
2011-10-14	Integra LifeSciences Corp.	A loose screw may result in shifting of components and improper function of the turret or actuator assembly.
2011-03-07	Integra LifeSciences Corp.	Malfunction of the MLX Control Board may cause loss of manual control and Lamp shut down.

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Data 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.