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U.S. Department of Health and Human Services

Class 2 Device Recall Harmony LC 500

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 Class 2 Device Recall Harmony LC 500see related information
Date Initiated by FirmFebruary 23, 2010
Date PostedApril 01, 2010
Recall Status1 Terminated 3 on June 04, 2012
Recall NumberZ-1220-2010
Recall Event ID 54742
510(K)NumberK013242 
Product Classification Lamp, surgical - Product Code FTD
ProductHarmony Lux Classic, Surgical Lighting System, also known as the Harmony LC 500, B129388085 and B12988086. 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 0436005042-0430207104
Recalling Firm/
Manufacturer		 Steris Corporation
5960 Heisley Rd
Mentor OH 44060
For Additional Information ContactStephen Norton
440-392-7482
Manufacturer Reason
for Recall		Premature Bulb Failure
FDA Determined
Cause 2		Device Design
ActionSTERIS 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 Commerce3,953 units
DistributionWorldwide 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 CycleTPLC 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) Database510(K)s with Product Code = FTD
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