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Recall Observatory FDA recall evidence

Device 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.

Z-0930-2015

November 26, 2014

Class II

Product summary

Firm
Steris Corporation
Event
Event 69987
Status
Terminated
Classification
Class II
Quantity
140 units
Official record key
device-enforcement:Z-0930-2015

Official wording

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

Code information: The following item numbers are included in this recall: B136824175, B136824176, B136824177, B136824178, B136824179, B136824427, B136824430, B136824431, LK01N, and LK05N.

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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