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U.S. Department of Health and Human Services

Class 2 Device Recall Drager Sola 500 Surgical Lamp and Steris Harmony LL 500 Surgical Lamp

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  Class 2 Device Recall Drager Sola 500 Surgical Lamp and Steris Harmony LL 500 Surgical Lamp see related information
Date Initiated by Firm January 09, 2004
Date Posted January 22, 2004
Recall Status1 Terminated 3 on August 19, 2004
Recall Number Z-0358-04
Recall Event ID 28101
510(K)Number K010724  
Product Classification Lamp, Surgical - Product Code FTD
Product Drager Sola 500 Surgical Lamp and Steris Harmony LL 500 Surgical Lamp
Code Information Catalog numbers 4115571, YG18568, YG19051, and YG19262
Recalling Firm/
Manufacturer		 Draeger Medical, Inc.
3135 Quarry Rd
Telford PA 18969-1042
For Additional Information Contact James Brennan
215-721-5400
Manufacturer Reason
for Recall		 adjustment screw may break due to material fatigue
FDA Determined
Cause 2		 Other
Action The recalling firm issued a recall letter dated 1/9/03 to their direct accounts. The recall letter informed the accounts of the problem, the potential danger, and that they will be contacted to schedule replacement.
Quantity in Commerce 51 units
Distribution Nationwide and Canada. The products were shipped to medical facilities in CA, CO, FL, GA, IL, IN, KS, MO, NC, NV, OH, TX, and VA. The product was also shipped to a medical facility in 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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