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U.S. Department of Health and Human Services

Class 2 Device Recall Harmony LL 500 and Harmony LL 700

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  Class 2 Device Recall Harmony LL 500 and Harmony LL 700 see related information
Date Initiated by Firm April 04, 2014
Date Posted June 23, 2014
Recall Status1 Terminated 3 on October 15, 2014
Recall Number Z-1850-2014
Recall Event ID 68128
510(K)Number K010724  
Product Classification ceiling mounted surgical light system - Product Code FSY
Product Vertical Spring Arm for Single or Dual Monitor Mount (Harmony LL 500 and Harmony LL 700 surgical lighting systems), Steris Corporation. Model numbers YG19051 and YG19262.
Code Information Model #: YG19051, Serial #'s: 01108340587, 01117338881, 011106337516, 011106337525, 011106337527, 011106337534, 011106337535, 011106337538, 011106337539, 011106337541, 011106337626, 011107338878, 011107338882, 011107338883, 011108340587, 011108340600, 0111073388883 & 011108340600A.  Model #: YG19262, Serial #: ART00001 - ART00010, CADS0001 - CADS0015, CBX0001 - CBX0010 & CXSG0008 - CXSG0022.
Recalling Firm/
Manufacturer		 Steris Corporation
5960 Heisley Rd
Mentor OH 44060-1834
For Additional Information Contact Ms. Kathryn E. Cadorette
440-392-7231
Manufacturer Reason
for Recall		 Potential for the welded seam in affected monitor spring arms to crack and/or break.
FDA Determined
Cause 2		 Device Design
Action On April 11, 2014 the firm sent Urgent Voluntary Field Correction Notices to their customers.
Quantity in Commerce 68 units
Distribution Distribution to US (states: MA, NY, OH, PA & TX) and Canada.
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 = DRAGER MEDIZINTECHNIK GMBH
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