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U.S. Department of Health and Human Services

Class 2 Device Recall Harmony vLED Surgical Lighting System

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  Class 2 Device Recall Harmony vLED Surgical Lighting System see related information
Date Initiated by Firm November 26, 2014
Date Posted January 07, 2015
Recall Status1 Terminated 3 on July 11, 2015
Recall Number Z-0930-2015
Recall Event ID 69987
510(K)Number K100395  
Product Classification Light, surgical, fiberoptic - Product Code FST
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.
Code Information The following item numbers are included in this recall:  B136824175, B136824176, B136824177, B136824178, B136824179, B136824427, B136824430, B136824431, LK01N, and LK05N.
Recalling Firm/
Manufacturer		 Steris Corporation
5960 Heisley Rd
Mentor OH 44060-1834
For Additional Information Contact Kathryn E. Cadorette
440-392-7231
Manufacturer Reason
for Recall		 STERIS has learned that groups of LED lights (modules) contained within the vLED light head may illuminate inconsistently.
FDA Determined
Cause 2		 Software Design Change
Action 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.
Quantity in Commerce 140 units
Distribution 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = FST and Original Applicant = STERIS Corporation
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