Class 2 Device Recall Fabius GS Anesthesia Machine

• Date Initiated by Firm: October 03, 2006
• Date Posted: October 19, 2006
• Recall Status: Terminated on August 07, 2007
• Recall Number: Z-0048-2007
• Recall Event ID: 36476
• 510(K)Number: K042419
• Product Classification: Anesthesia Machine - Product Code BSZ
• Product: Fabius GS Anesthesia Machine. Catalog number 8604699
• Code Information: Catalog number 8604699
• FEI Number: 2517967
• Recalling Firm/ Manufacturer: Draeger Medical, Inc.; 3135 Quarry Rd; Telford PA 18969-1042
• For Additional Information Contact: Technical Support; 800-543-5047
• Manufacturer Reason for Recall: One of four casters may break loose from chassis
• FDA Determined Cause: Other
• Action: The recalling firm issued recall letters to their customers 10/03/2006 to inform them of the problem and that a service represenative will contact them to schedule an inspection of their machines. Should the inspections revealed any affected machines, the machines will be repaired free of charge.
• Quantity in Commerce: 429 units
• Distribution: Nationwide 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 = BSZ