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

Recalled January 14, 2015 · FDA recall Z-0930-2015 · Steris

Hazard

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

Units

140 units

Sold at

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, and Virginia and Internationally to Canada, China, Greece, Indonesia, Republic of Korea, Romania, Russian Federation, Taiwan, and Viet Nam.

Description

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

Product

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.

Manufacturer(s)

Steris Corporation

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →