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U.S. Department of Health and Human Services

Class 2 Device Recall STERIS Harmony LL 500/700 Surgical Light

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  Class 2 Device Recall STERIS Harmony LL 500/700 Surgical Light see related information
Date Initiated by Firm September 11, 2009
Date Posted November 23, 2009
Recall Status1 Terminated 3 on March 01, 2012
Recall Number Z-0414-2010
Recall Event ID 53475
510(K)Number K010724  
Product Classification Surgical Lamp - Product Code FTD
Product STERIS Harmony LL 500/700 Surgical Light, Vertical Spring-Loaded Arm.

Intended for local illumination of the operating and examination area of the patient in treatment rooms.
Code Information Part Number: YG18568; Serial Numbers: Year 2002 - 0111 072 XXXXX to 0111 122 XXXXX; Year 2003-0111 013 XXXXX to 0111 123 XXXXX; Year 2004-0111 014 XXXXX to 0111 124 XXXXX; Year 2005-0111 015 XXXXX to 0111 125 XXXXX; and Year 2006-0111 016 XXXXX to 0111 066 XXXXX - (XXXXX means every 5-digit serial number).
Recalling Firm/
Manufacturer		 Steris Corp
5960 Heisley Rd
Mentor OH 44060
For Additional Information Contact Barbara Rich
440-392-7318
Manufacturer Reason
for Recall		 Dr¿ger Medical AG & Co., KGaA informed STERIS Corporation that they received (4) reported international cases where a welded seam at the joint of the spring-loaded arm of the Dr¿ger SOLA 500/700 surgical light broke as a result of a crack that had slowly developed over time. The STERIS Harmony LL 500/700 surgical light is a Private Label version of the Dr¿ger SOLA 500/700 surgical light.
FDA Determined
Cause 2		 Device Design
Action The firm sent Urgent Product Correction letters, dated Sept. 11, 2009, to their customers. The letter identified the problem and stated that Drager had supplied STERIS the replacement spring arms and that a STERIS Service Technician would perform the replacement. The letter also stated that the correction would be performed at no charge to the customers. According to the letter, customers would be contacted by their STERIS Service Representative to arrange a convenient time for replacement of potentially affected spring arms. In the meantime, the letter states that customers should use their surgical lights in accordance with the guidelines presented in the Operator's Manual. Questions or concerns regarding the letter should be directed to Barbara Rich at 440-392-7318 or your local STERIS account manager.
Quantity in Commerce 388 units
Distribution Worldwide Distribution -- USA, including the states of AL, AR, CA, CO, CT, FL, GA, HI, IL, IN, KS, LA, MA, MN, MO, MS, NC, NH, NJ, NV, NY, OH, PA, RI, SC, TN, TX, UT, VA, WA, WI & WY and the country of 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 = FTD and Original Applicant = DRAGER MEDIZINTECHNIK GMBH
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