| Class 2 Device Recall Harmony LA 500 | |
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
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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/ Manufacturer |
Steris Corporation 5960 Heisley Rd Mentor OH 44060
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For Additional Information Contact | Stephen Norton 440-392-7482 |
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 |
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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.
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510(K) Database | 510(K)s with Product Code = FTD
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