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U.S. Department of Health and Human Services

Class 2 Device Recall Harmony LA/LED Arm Adapter

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  Class 2 Device Recall Harmony LA/LED Arm Adapter see related information
Date Initiated by Firm February 18, 2011
Date Posted April 05, 2011
Recall Status1 Terminated 3 on March 13, 2013
Recall Number Z-1886-2011
Recall Event ID 58107
510(K)Number K013242  K072072  
Product Classification Light, surgnical, ceiling mounted - Product Code FSY
Product Harmony LA/LED Monitor Arm Adapter. Model Number: LB61
The Harmony LA/LED Monitor Arm Adapter is an accessory to the Harmony LA and LED Surgical Lighting System and is attached to the end of the monitor suspension arm to allow Customers to attach other medical devices, such as non-STERIS monitors, camera or other compatible items in place of the STERIS monitor. The Harmony Surgical Lighting and Media System is a family of variable pattern, variable intensity surgical lights designed to provide visible immunization of the surgical field or the patient and to provide audio-visual procedural support for the O.R. staff. The device is intended to be used by surgeons and other medical care practitioners in a surgical setting
Code Information Model Number: LB61
Recalling Firm/
Steris Corporation
5960 Heisley Rd
Mentor OH 44060
For Additional Information Contact
Manufacturer Reason
for Recall
The arm adapter does not contain labelling specifying the applicable weight and moment limitations of the arm adapter
FDA Determined
Cause 2
Action Steris Corporation sent an Urgent Field Correction Notice letter dated February 18, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. A Steris representative would contact customers to arrange for replacement of the product. For questions regarding the firms visit to their facility, customers were instructed to contact Steris Field Service Dispatch at 1-800-333-8828. For any questions regarding this matter call 440-392-7705.
Quantity in Commerce 14 Units
Distribution Worldwide Distribution - USA including CO, IL, IN, MO, NC, NV, NY and OH and the countrries of Canada, China, and Australia.
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 = FSY and Original Applicant = STERIS Corporation