Steris Corporation recalls Harmony¿ vLED Surgical Lighting System, one unit packaged per box The Harmony¿ vLED Surgical Lighting System is a varia…

Recall date

November 26, 2014

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0930-2015

FDA classification

Class II

Brand / firm

Steris Corporation

Sold / distributed

Worldwide Distribution - USA including Alabama, Alaska, Arkansas, California, District of Columbia, Florida, Illinois, Indiana, Kansas, Louisiana, Mississippi, Nevada, New Jersey, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, an…

Why it was recalled

STERIS has learned that groups of LED lights (modules) contained within the vLED light head may illuminate inconsistently.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.