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

• Date Initiated by Firm: January 09, 2004
• Date Posted: January 22, 2004
• Recall Status: Terminated 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
• FEI Number: 2517967
• 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: 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