—#132078

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.

FDA product code: FST — Light, Surgical, Fiberoptic
Device class: Class 2
Medical specialty: General, Plastic Surgery
510(k) numbers: K100395
Affected lot / code info: The following item numbers are included in this recall: B136824175, B136824176, B136824177, B136824178, B136824179, B136824427, B136824430, B136824431, LK01N, and LK05N.

Why it was recalled

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

Root cause (FDA determination)

Software Design Change

Action the firm took

STERIS sent an Urgent Voluntary Field Correctionn Notice to all affected consignees via FedEx. The Consignee Notification mailing was initiated the week of December 15, 2014. Customers were instructed that their local STERIS representative would contact their facility to arrange for the installation of updated software. Customers with questions were instructed to call 1-800-548-4873. For questions regarding this recall call 440-392-7231.

Recalling firm

Firm: Steris Corporation
Address: 5960 Heisley Rd, Mentor, Ohio 44060-1834

Distribution

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.

Timeline

Recall initiated: 2014-11-26
Posted by FDA: 2015-01-07
Terminated: 2015-07-11
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #132078. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.