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U.S. Department of Health and Human Services

Class 2 Device Recall Harmony LA 500

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  Class 2 Device Recall Harmony LA 500 see related information
Date Initiated by Firm February 23, 2010
Date Posted April 01, 2010
Recall Status1 Terminated 3 on June 04, 2012
Recall Number Z-1218-2010
Recall Event ID 54742
510(K)Number K013242  
Product Classification Lamp, surgical - Product Code FTD
Product Harmony Lux Advantage LA Surgical Lighting and Visualization System, also known as the Harmony LA 500, B129382391.

Designed to provide visible immunization of the surgical field or the patient and to provide audio-visual procedural support for the O.R. staff. Intended to be used in a surgical setting.
Code Information Serial Numbers 0428102135-0428307020
Recalling Firm/
Steris Corporation
5960 Heisley Rd
Mentor OH 44060
For Additional Information Contact Stephen Norton
Manufacturer Reason
for Recall
Premature Bulb Failure
FDA Determined
Cause 2
Device Design
Action STERIS issued an "Urgent Field Correction Notice" dated February 23, 2010 via Fed Ex. Consignees were informed of the affected product and were instructed on proper handeling of the device until a STERIS Service Technician contacts the consignee to schedule a service visit. For further information, contact STERIS Field Service Dispatch at 1-800-8828.
Quantity in Commerce 10,433 units
Distribution Worldwide Distribution -- United States, Canada, Algeria, Australia, Bahrain, Bangladesh, Brazil, Chile, China, Costa Rica, Ecuador, El Salvador, France, Germany, Guam, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Malaysia, Mexico, New Zealand, Nigeria, Pakistan, Philippines, Poland, Qatar, Russia, Saudi Arabia, South Africa, South Korea, Spain, Taiwan, Thailand, Turkey, United Arab Emirates, United Arab Emirates, United Kingdom, Italy, Yemen and United Arab Emirates.
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 = FTD and Original Applicant = STERIS Corporation